ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02080455
Conditions: Effect of Atorvastatin on the Pharmacokinetics of Lomitapide
Sponsor: Aegerion Pharmaceuticals, Inc.
Start date: 2014-01-27; Completion date: 2014-03-07
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the effect of atorvastatin, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of lomitapide and its 2 primary metabolites, M1 and M3.

Detailed description:
This study will be a single center, randomized, open-label, 2-arm study to evaluate the effects of atorvastatin, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy male and female subjects when atorvastatin is administered simultaneously with lomitapide and when it is administered 12 hours after lomitapide.

Arms: arm 1: 2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 \& Day 15)

11 single oral doses of atorvastatin (80 mg) (Day 11 through day 21) arm 2: 2 single oral doses of lomitapide (20 mg) with a 14-day washout between (Day 1 \& Day 15)

11 single oral doses of atorvastatin (80 mg) (Day 12 through day 22)
Interventions: intervention 1: lomitapide intervention 2: Atorvastatin
Intervention descriptions: intervention 1: 20 mg dose intervention 2: 80 mg

Protocol documents:
Clinical trial NCT01522651
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation Ranolazine Dronedarone Dual Chamber Pacemakers
Sponsor: Gilead Sciences
Start date: 2012-01-24; Completion date: 2014-03-10
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the effect of ranolazine and of low-dose dronedarone when given alone and in combination at different dose levels on atrial fibrillation burden (AFB) over 12 weeks of treatment. AFB is defined as the total time a participant is in atrial tachycardia/atrial fibrillation (AT/AF) expressed as a percentage of total recording time.

Detailed description:

Arms: arm 1: Ranolazine placebo plus dronedarone placebo for 12 weeks. arm 2: Ranolazine 750 mg plus dronedarone placebo for 12 weeks. arm 3: Ranolazine placebo plus dronedarone 225 mg for 12 weeks. arm 4: Ranolazine 750 mg plus dronedarone 225 mg for 12 weeks. arm 5: Ranolazine 750 mg plus dronedarone 150 mg for 12 weeks.
Interventions: intervention 1: Ranolazine intervention 2: Dronedarone intervention 3: Ranolazine placebo intervention 4: Dronedarone placebo
Intervention descriptions: intervention 1: Tablets administered orally twice daily. intervention 2: Capsule administered orally twice daily intervention 3: Tablets administered orally twice daily. intervention 4: Capsules administered orally twice daily

Protocol documents:
Clinical trial NCT01676116
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2012-08-29; Completion date: 2014-03-11
Enrollment: 438 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/liraglutide intervention 2: liraglutide intervention 3: exenatide
Intervention descriptions: intervention 1: Injected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial OAD treatment without changing the frequency or dose throughout the trial. intervention 2: Subjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial. intervention 3: Subjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.

Protocol documents:
Clinical trial NCT01890109
Conditions: Vasomotor Symptoms; Hot Flashes
Keywords: Vasomotor symptoms; Hot Flashes; Menopause
Sponsor: Amgen
Start date: 2013-05-13; Completion date: 2014-03-11
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to evaluate the frequency of moderate to severe daily hot flashes 4 weeks after a single dose of erenumab (AMG 334) in women with hot flashes associated with menopause.

Detailed description:
This study will test the hypothesis that the vasodilation associated with capsaicin-induced dermal blood flow (DBF) provides a good model for the vasodilation associated with hot flashes; therefore erenumab doses that cause DBF inhibition will be safe and well tolerated, and will be effective in the reduction of the frequency and/or severity of HFs.

Arms: arm 1: Participants received a single dose of placebo administered by subcutaneous injection. arm 2: Participants received a single dose of 70 mg erenumab administered by subcutaneous injection.
Interventions: intervention 1: Erenumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered via subcutaneous injection. intervention 2: Administered via subcutaneous injection

Protocol documents:
Clinical trial NCT01716156
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-01-18; Completion date: 2014-03-12
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare two different durations of treatment with grazoprevir (MK-5172) in combination with ribavirin (RBV) in treatment-naïve non-cirrhotic interferon-eligible interleukin 28b CC (IL28B CC) genotype participants with genotype 1 (GT1)-positive chronic hepatitis C (CHC). Participants will be randomized to receive 12 or 24 weeks of combination therapy.

Detailed description:

Arms: arm 1: Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment. arm 2: Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
Interventions: intervention 1: Grazoprevir intervention 2: Ribavirin
Intervention descriptions: intervention 1: Grazoprevir, tablet, orally, 100 mg, once per day for 12 or 24 weeks, depending on Arm assignment intervention 2: Ribavirin capsules, orally, twice per day, at a total daily dose from 800 to 1400 mg based on participant weight

Protocol documents:
Clinical trial NCT01418352
Conditions: Tourette's Disorder
Keywords: Tourette's Disorder Tic disorders
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-08-02; Completion date: 2014-03-12
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the current trial is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.

Detailed description:

Arms: arm 1: Participants received aripiprazole matching placebo, tablets, orally, once weekly for 8 weeks in the Double-blind Treatment Period. arm 2: Participants received aripiprazole 52.5 mg, tablets, orally, once weekly for 8 weeks in the Double-blind Treatment Period. arm 3: Participants received aripiprazole 77.5 mg, tablets, orally, once weekly for 8 weeks in the Double-blind Treatment Period. arm 4: Participants received aripiprazole 110 mg, tablets, orally, once weekly for 8 weeks in the Double-blind Treatment Period.
Interventions: intervention 1: Aripiprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Aripiprazole tablets once weekly for 8 weeks. intervention 2: Aripiprazole matching-placebo once-weekly for 8 weeks.

Protocol documents:
Clinical trial NCT01416441
Conditions: Tourette's Disorder
Keywords: Tourette's Disorder Tic Disorders
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-10-19; Completion date: 2014-03-13
Enrollment: 170 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of the current trial is to obtain long term efficacy, safety and tolerability data of once weekly aripiprazole in children and adolescents with Tourette's Disorder.

Detailed description:

Arms: arm 1: Participants received oral aripiprazole tablets once weekly (QW) with a titrated dose starting from 52.5 milligram (mg), on Day 1 and increasing to 77.5 mg and 110 mg for the remainder of the trial (Up to Week 52), the dose could be adjusted between these 3 dose levels as determined by investigator's discretion based on safety and tolerability.
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: Aripiprazole tablets orally once daily.

Protocol documents:
Clinical trial NCT01916967
Conditions: Urticaria
Keywords: Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents
Sponsor: Organon and Co
Start date: 2013-08-27; Completion date: 2014-03-13
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with chronic urticaria. The primary hypothesis is that the efficacy of desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.

Detailed description:

Arms: arm 1: Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks arm 2: Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks arm 3: Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
Interventions: intervention 1: Desloratadine intervention 2: Placebo
Intervention descriptions: intervention 1: Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks intervention 2: Placebo tablets, given orally, once daily in the evening for 2 weeks

Protocol documents:
Clinical trial NCT01370642
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-06-27; Completion date: 2014-03-17
Enrollment: 294 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of participants achieving SVR24 in the control arm.

Detailed description:

Arms: arm 1: Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV. arm 2: Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV. arm 3: Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
Interventions: intervention 1: vaniprevir intervention 2: Placebo to vaniprevir intervention 3: Peg-IFN intervention 4: ribavirin
Intervention descriptions: intervention 1: Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks intervention 2: Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks intervention 3: Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks intervention 4: Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks

Protocol documents:
Clinical trial NCT01557842
Conditions: Ventricular Tachycardia Ischemic
Keywords: Ischemic Ventricular Tachycardia Implantable Cardioverter Defibrillators Antiarrhythmic Drug Therapy Ablation Electrophysiology
Sponsor: Biosense Webster, Inc.
Start date: 2012-06-01; Completion date: 2014-03-19
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic ventricular tachycardia in patients with Implantable Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia despite drug therapy.

Detailed description:

Arms: arm 1: This group receives radiofrequency catheter ablation and drug treatment. arm 2: This group receives only drug treatment.
Interventions: intervention 1: Drug Treatment intervention 2: Catheter Ablation
Intervention descriptions: intervention 1: Class I and III antiarrhythmic drug treatment. intervention 2: Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment.

Protocol documents:
Clinical trial NCT01803555
Conditions: Asthma
Keywords: Budesonide/Formoterol SPIROMAX® SYMBICORT® TURBOHALER® Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2013-07-04; Completion date: 2014-03-20
Enrollment: 605 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) Spiromax 160/4.5 micrograms (mcg) is as effective as Symbicort Turbohaler 200/6 mcg administered twice daily in participants with persistent asthma.

Detailed description:

Arms: arm 1: 2 inhalations of BF Spiromax at a dosage of 160/4.5 mcg and 2 inhalations of SYMBICORT placebo administered twice daily (AM and PM) during the 12-week treatment period. arm 2: 2 inhalations of SYMBICORT TURBOHALER at a dosage of 200/6 mcg and 2 inhalations of placebo SPIROMAX administered twice daily (AM and PM) during the 12-week treatment period.
Interventions: intervention 1: Budesonide/Formoterol SPIROMAX® intervention 2: SYMBICORT® TURBOHALER® intervention 3: SYMBICORT placebo intervention 4: SPIROMAX Placebo
Intervention descriptions: intervention 1: BF Spiromax will be administered per dose and schedule specified in the arm. intervention 2: Symbicort Turbohaler will be administered per dose and schedule specified in the arm. intervention 3: SYMBICORT placebo multi-dose dry powder inhaler (DPI) identical in appearance to SYMBICORT TURBOHALER will be administered per dose and schedule specified in the arm. intervention 4: SPIROMAX Placebo multi-dose dry powder inhaler (DPI) identical in appearance to BF SPIROMAX will be administered per dose and schedule specified in the arm.

Protocol documents:
Clinical trial NCT01916980
Conditions: Eczema Dermatitis Dermal Pruritus
Keywords: Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases
Sponsor: Organon and Co
Start date: 2013-08-27; Completion date: 2014-03-22
Enrollment: 94 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an efficacy and safety study of up to 12 weeks of desloratadine in Japanese participants with eczema/dermatitis and dermal pruritus. The primary hypothesis of this study is that the sum of the daytime and nighttime pruritus/itch scores for both the eczema/dermatitis group and the dermal pruritus group will be significantly improved at Week 2 compared to Baseline.

Detailed description:

Arms: arm 1: Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient antipruritic efficacy and there is no safety concern. arm 2: Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
Interventions: intervention 1: Desloratadine 5 mg
Intervention descriptions: intervention 1: Desloratadine 5 mg/day: one 5-mg tablet taken orally once daily in the evening for up to 12 weeks (Desloratadine 10 mg/day: two 5-mg tablets taken orally once daily in the evening for up to 8 weeks)

Protocol documents:
Clinical trial NCT01782664
Conditions: Psoriasis
Keywords: PASI DLQI GSK2586184 plaque-type psoriasis PGA inflammatory gene transcription JAK-1 inhibitor serum neopterin skin biopsy ACR response criteria VAS itch score
Sponsor: GlaxoSmithKline
Start date: 2013-03-01; Completion date: 2014-03-24
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multi-centre, randomised, dose ranging study to evaluate the safety and clinical efficacy of GSK2586184 in patients with chronic plaque psoriasis.

There will be 2 study cohorts (Cohorts A and B). Cohort A is the main study cohort, and this part of the study will be randomised, double-blind and placebo-controlled. Fifty-six subjects will be randomised in Cohort A: 14 subjects in each treatment group: 100 mg, 200 mg or 400 mg GSK2586184, or placebo. Cohort B is an exploratory, open-label investigation of the effect of 400 mg GSK2586184 on inflammatory gene expression in the skin and whole blood, and GSK2586184 concentrations in the skin. A maximum of 8 subjects will be included, and all subjects will take 400 mg GSK2586184.

In both Cohorts A and B, study medication will be administered orally (as tablets), twice daily, for up to 12 weeks.

Each subject will have 7 out-patient visits: Screening; Baseline \& Start of treatment; Week 2; Week 4; Week 8; Week 12; and Follow-up (Week 16)

Detailed description:

Arms: arm 1: Subjects will be randomized to 100 mg GSK2586184 twice daily for up to 84 days arm 2: Subjects will be randomized to 200 mg GSK2586184 twice daily for up to 84 days arm 3: Subjects will be randomized to 400 mg GSK2586184 twice daily for up to 84 days arm 4: Subjects will be randomized to receive Placebo twice daily for up to 84 days arm 5: Subjects will take 400 mg GSK2586184 twice daily for up to 84 days
Interventions: intervention 1: 100 mg GSK2586184 intervention 2: 200 mg GSK2586184 intervention 3: 400 mg GSK2586184 intervention 4: Placebo
Intervention descriptions: intervention 1: 100 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days. intervention 2: 200 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days. intervention 3: 400 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days. intervention 4: Placebo tablets to be taken twice daily with food for up to 84 days.

Protocol documents:
Clinical trial NCT02446483
Conditions: Gastrointestinal Diseases
Keywords: Idiazole 20mg PARIET 20 mg Rabeprazole bioequivalence
Sponsor: GlaxoSmithKline
Start date: 2014-03-19; Completion date: 2014-03-26
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is an open-label, randomized, single dose, two-sequence, two-period crossover study, separated by 7 days washout interval from the first study drug administration.

In this study, the bioavailability of Rabeprazole from Idiazole 20 milligram (mg) delayed release (DR) tablets and PARIET 20 mg DR tablets after a single oral dose administration of each to healthy adults under fasting conditions, will be investigated by determining the 90% confidence limits for the log-transformed ratio (Test product / Reference product) for the bioequivalence parameters. The influence of sequence, product and period effect will be tested by analysis of variance (ANOVA).

In this study a total of 60 subjects plus 1-4 additional subjects will be enrolled and split into two groups (Group A and B) of 30 each. For each subject, a total of 33 blood draws will be done and the volume of blood will not exceed 300 milliliters (mL) for the study.

PARIET is a registered trademark of EISAI Co. Limited.

Detailed description:

Arms: arm 1: Thirty subjects will receive a single oral dose of idiazole 20mg DR tabs under fasting condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of PARIET 20 mg DR tabs under fasting condition in treatment period 2. arm 2: Thirty subjects will receive a single oral dose of PARIET 20 mg DR tabs under fasting condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of idiazole 20mg DR tabs under fasting condition in treatment period 2.
Interventions: intervention 1: Idiazole 20mg DR tabs intervention 2: PARIET 20 mg DR tabs
Intervention descriptions: intervention 1: Delayed release tablets containing 20 mg of rabeprazole intervention 2: Orally administered, delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.

Protocol documents:
Clinical trial NCT01436175
Conditions: Major Depressive Disorder
Sponsor: Shire
Start date: 2012-02-27; Completion date: 2014-03-27
Enrollment: 1570 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
Intervention descriptions: intervention 1: SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks

Protocol documents: