ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00931710
Conditions: Stage 2 Systolic Hypertension
Keywords: Hypertension combination therapy valsartan cardiovascular diseases
Sponsor: Novartis
Start date: 2009-07-01; Completion date: 2010-01-01
Enrollment: 488 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

Detailed description:

Arms: arm 1: Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study. arm 2: Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
Interventions: intervention 1: valsartan, amlodipine, HCTZ intervention 2: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ
Intervention descriptions: intervention 1: combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study intervention 2: losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCTZ 25 mg capsule for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (3 weeks) of the study

Protocol documents:
Clinical trial NCT00938548
Conditions: Pain, Postoperative
Keywords: mastectomy pain, postoperative pregabalin
Sponsor: Severance Hospital
Start date: 2009-06-01; Completion date: 2010-01-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be VNRS at 1 week and 1 month after operation.

Detailed description:

Arms: arm 1: Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later arm 2: Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
Interventions: intervention 1: Pregabalin intervention 2: Vitamin Complex (placebo)
Intervention descriptions: intervention 1: Pregabalin 75 mg orally intervention 2: Vitamin Complex orally

Protocol documents:
Clinical trial NCT00949884
Conditions: Hypertension
Sponsor: Daiichi Sankyo
Start date: 2009-08-01; Completion date: 2010-01-01
Enrollment: 941 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of the FDA approved blood pressure medication olmesartan medoxomil compared to the FDA approved medication losartan potassium.

Detailed description:

Arms: arm 1: Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks. arm 2: Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks arm 3: Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
Interventions: intervention 1: olmesartan medoxomil intervention 2: Placebo intervention 3: losartan potassium
Intervention descriptions: intervention 1: Oral tablets, once daily, at either 20mg or 40mg daily. intervention 2: placebo oral tablets once daily for two weeks intervention 3: losartan potassium oral tablet at either 50mg or 100 mg daily dose.

Protocol documents:
Clinical trial NCT00980200
Conditions: Asthma
Keywords: GW642444 once daily dosing asthma efficacy safety FEV1
Sponsor: GlaxoSmithKline
Start date: 2009-09-01; Completion date: 2010-01-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment.

Detailed description:
The study will be a five-period cross-over study with each 7 day treatment period separated by a 7 day wash-out period. The study will enroll asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment with an FEV1 of between 40-85% of predicted normal and with airway reversibility as demonstrated by an increase in FEV1 of ≥12% and ≥200ml .

Efficacy assessments include 24-hour serial lung function testing. Safety assessments include incidence of adverse events and measurement of vital signs.

Arms: arm 1: GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD/GW642444 Dose 3 QD arm 2: GW642444 Dose 3 QD/GW642444 Dose 2 QD/GW642444 Dose 4 QD/placebo/GW642444 Dose 1 BD arm 3: placebo/GW642444 Dose 1 BD/GW642444 Dose 2 QD/GW642444 Dose 3 QD/GW642444 Dose 4 QD arm 4: GW642444 Dose 1 BD/placebo/GW642444 Dose 3 QD/GW642444 Dose 4 QD/GW642444 Dose 2 QD arm 5: GW642444 Dose 4 QD/GW642444 Dose 3 QD/GW642444 Dose 1 BD/GW642444 Dose 2 QD/placebo
Interventions: intervention 1: Dose 4 QD intervention 2: Dose 3 QD intervention 3: placebo intervention 4: Dose 2 QD intervention 5: Dose 1 BD
Intervention descriptions: intervention 1: QD once daily intervention 2: QD once daily intervention 3: placebo intervention 4: QD once daily intervention 5: BD twice daily

Protocol documents:
Clinical trial NCT00985543
Conditions: Acquired Immunodeficiency Syndrome
Keywords: HIV ART HAART Pharmacokinetics Lopinavir/ritonavir Lower dose selection
Sponsor: Kirby Institute
Start date: 2009-10-01; Completion date: 2010-01-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir over a 12-hour dosing interval, following administration to male and female HIV-negative healthy volunteers of:

1. Lopinavir/ritonavir 400/100 mg twice daily
2. Lopinavir/ritonavir 200/150 mg twice daily
3. Lopinavir/ritonavir 200/50 mg twice daily

Detailed description:
Data during the development of lopinavir/ritonavir showed that lower drug doses had similar efficacy to the standard dose of 400/100mg twice daily. Lower drug doses are also associated with limited toxicity and cost.

The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir following administration to male and female HIV-negative volunteers of 400/100mg, 200/150mg and 200/50mg lopinavir/ritonavir twice daily. Each dosing phase will last for 7 days and each phase will be separated by a 7-day wash-out period. Pharmacokinetic evaluations will be made over a 12-hour interval at the end of each dosing phase.

Healthy subjects as determined by their medical history and physical examinations will be eligible to participate in the study. HIV-positive subjects will not be recruited as there is a risk that HIV-resistant mutations will be selected by an experimentally reduced dose of lopinavir/ritonavir. There is no reason to presume that there is any meaningful difference in the metabolic processing of lopinavir/ritonavir between HIV-infected and HIV-uninfected people.

Arms: arm 1: Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID)) arm 2: Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID) arm 3: Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)
Interventions: intervention 1: lopinavir/ritonavir
Intervention descriptions: intervention 1: Each participant received three sequential doses of lopinavir/ritonavir: 400/100 mg twice daily (2 heat-stable 200/50 mg tablets BID), 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID), and 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period.

Protocol documents:
Clinical trial NCT01001806
Conditions: Cataracts
Sponsor: Frank A. Bucci, Jr., M.D.
Start date: 2009-10-01; Completion date: 2010-01-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.

Detailed description:

Arms: arm 1: Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery arm 2: Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery arm 3: One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery
Interventions: intervention 1: Ketorolac Tromethamine 0.45% intervention 2: bromfenac 0.09% intervention 3: nepafenac 0.1%
Intervention descriptions: intervention 1: One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery intervention 2: One day pre operative 1 drop BID then 3 doses pre op day of surgery intervention 3: One drop BID, 1 day pre operative and then 3 doses the day of surgery

Protocol documents:
Clinical trial NCT01005719
Conditions: Human Experimentation
Sponsor: Bayer
Start date: 2009-09-01; Completion date: 2010-01-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will determine differences between Proton Pump Inhibitors (PPI) formulations relative to their effects on gastric acidity.

Detailed description:

Arms: arm 1: Participants receiving Zegerid (omeprazole/sodium bicarbonate) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication. arm 2: Participants receiving Prevacid® (lansoprazole) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication. arm 3: Participants receiving No treatment in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants took approximately 2 oz of water once daily for 7 days.
Interventions: intervention 1: Zegerid intervention 2: Prevacid®
Intervention descriptions: intervention 1: Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days. intervention 2: Prevacid (15 mg lansoprazole) taken with approximately 2 oz of water once daily for 7 days.

Protocol documents:
Clinical trial NCT01021761
Conditions: Cataracts
Sponsor: Frank A. Bucci, Jr., M.D.
Start date: 2009-10-01; Completion date: 2010-01-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.

Detailed description:

Arms: arm 1: Xibrom to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery arm 2: Nevanac to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery arm 3: Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery.
Interventions: intervention 1: Ketorolac Tromethamine intervention 2: Bromfenac intervention 3: nepafenac
Intervention descriptions: intervention 1: ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery intervention 2: Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery intervention 3: drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery

Protocol documents:
Clinical trial NCT01037452
Conditions: Heartburn
Keywords: Heartburn antacid PPI Lansoprazole calcium carbonate magnesium hydroxide Relief of heartburn following ingestion of a heartburn-inducing meal
Sponsor: Novartis
Start date: 2009-12-01; Completion date: 2010-01-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.

Detailed description:

Arms: arm 1: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet arm 2: Lansoprazole arm 3: Calcium carbonate/magnesium hydroxide arm 4: Placebo
Interventions: intervention 1: Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg intervention 2: Lansoprazole intervention 3: Calcium carbonate/magnesium hydroxide intervention 4: Placebo
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet intervention 3: Tablet intervention 4: Tablet

Protocol documents:
Clinical trial NCT01043146
Conditions: Heart Failure
Keywords: anti-beta1 adrenergic receptor autoantibody cyclic peptide heart failure
Sponsor: Corimmun GmbH
Start date: 2009-10-01; Completion date: 2010-01-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Trial objectives:

To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on verum per dose level, 10 subjects receiving placebo)

Secondary objectives:

To evaluate safety and tolerability by using adverse events (AEs) and vital signs

Detailed description:
Primary Trial objective:

To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in healthy, male volunteers after single intravenous administration

Secondary objectives:

To evaluate safety and tolerability by using adverse events (AEs), vital signs including blood pressure/pulse rate (BP/PR), electrocardiographic examinations (12 lead ECG), evaluation of antibody titer and safety laboratory tests (biochemistry, hematology, coagulation, urinalysis)

Methodology:

Mono-center, single-blind, dose escalating study with five dose levels (8 subjects on verum per dose level, 2 subjects receiving placebo) in a total of 50 volunteers.

Arms: arm 1: single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1 arm 2: intravenous 0.9 % NaCl
Interventions: intervention 1: COR-1 intervention 2: placebo
Intervention descriptions: intervention 1: single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1 intervention 2: intravenous 0.9 % NaCl

Protocol documents:
Clinical trial NCT01047436
Conditions: Falciparum Malaria
Keywords: Plasmodium infections Remittent fever Artemether Artemisinins quinine Malaria Protozoan Infections Anti-Infective Agents Antiprotozoal Agents Schistosomicides Pharmacologic Actions Malaria, Falciparum Antimalarials Antiparasitic Agents Parasitic Diseases sublingual
Sponsor: Proto Pharma Ltd
Start date: 2009-12-01; Completion date: 2010-01-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with gastrointestinal complications.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Quinine intervention 2: Artemether
Intervention descriptions: intervention 1: 20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy intervention 2: Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy

Protocol documents:
Clinical trial NCT01095835
Conditions: Hepatitis B, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2005-02-01; Completion date: 2010-01-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a treatment alone and in combination with lamivudine (LAM). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Treatment with PEG-IFN in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. arm 2: Treatment with PEG-IFN in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN treatment (total 96 weeks of treatment). arm 3: Treatment with PEG-IFN and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN treatment (total 96 weeks of treatment).
Interventions: intervention 1: Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg intervention 2: Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg intervention 3: Lamivudine (LAM)
Intervention descriptions: intervention 1: PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48. intervention 2: PEG-IFN alfa-2a 135 mcg was administered subcutaneously, once weekly from Week 49 to 96. intervention 3: Lamivudine 100 milligrams (mg) was administered orally, daily from Week 0 to 48.

Protocol documents:
Clinical trial NCT01709136
Conditions: Hypertension
Sponsor: University of Pittsburgh
Start date: 2005-12-01; Completion date: 2010-01-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Pharmacokinetics of Tacrolimus and Sirolimus alone and in combination in liver transplant recipients.

Detailed description:
Liver transplant patients receiving tacrolimus, and who experience side effects such as hypertension and renal dysfunction, will be converted to sirolimus with low-dose tacrolimus, or Tacrolimus withdrawal. This study will evaluate allograft function by serial clinical lab testing, the pharmacokinetics of sirolimus and tacrolimus, the glomerular filtration rate (GFR) and the potential side effect of sirolimus, such as marrow suppression and hyperlipidemia. Two pharmacokinetic evaluations are planned: once around the third post-transplant month and another one at about 12 months. Expected outcomes are, a better understanding of sirolimus pharmacokinetic parameters over time in pediatric/adult liver recipients and early efficacy and safety data of the sirolimus as a non-nephrotoxic alternative to tacrolimus.

Arms: arm 1: None
Interventions: intervention 1: Sirolimus
Intervention descriptions: intervention 1: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the Children's Hospital of Pittsburgh's Pediatric Clinical and Translational Research Center (PCTRC) - See more at: http://www.chp.edu/research/our-facilities/pctrc, and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.

Protocol documents:
Clinical trial NCT02006667
Conditions: Urinary Tract Cancer
Sponsor: Hoffmann-La Roche
Start date: 2001-01-01; Completion date: 2010-01-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The anticipated time on study treatment is until disease progression.

Detailed description:

Arms: arm 1: Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.) on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v until disease progression; 1200 mg per square meter (m2) gemcitabine i.v. on Days 1, 8, and 15 of Cycles 1 through 6; and 70 mg/m2 cisplatin i.v. on Day 2 of Cycles 1 through 6.
Interventions: intervention 1: trastuzumab intervention 2: gemcitabine intervention 3: cisplatin
Intervention descriptions: intervention 1: 4 mg/kg i.v., Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v., Day 1 of Cycle 2 until disease progression intervention 2: 1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6 intervention 3: 70 mg/m2 i.v. on Day 2 of Cycles 1 through 6

Protocol documents:
Clinical trial NCT02013765
Conditions: Urinary Tract Cancer
Sponsor: Hoffmann-La Roche
Start date: 2001-01-01; Completion date: 2010-01-01
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of intravenous Herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The anticipated time on study treatment is until disease progression.

Detailed description:

Arms: arm 1: Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by weekly doses of 2 mg/kg IV beginning on Day 8 and continuing for up to 37 weeks.
Interventions: intervention 1: trastuzumab
Intervention descriptions: intervention 1: Initial dose of 4 mg/kg i.v on Day 1, followed by weekly doses of 2 mg/kg i.v. beginning on Day 8 and continuing for up to 37 weeks.

Protocol documents: