ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01412060
Conditions: Schizophrenia
Keywords: Schizophrenia Schizophrenic disorder
Sponsor: Forest Laboratories
Start date: 2011-09-27; Completion date: 2014-09-03
Enrollment: 765 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.

Detailed description:
There were 3 periods (phases) in the study. The Open-label Phase lasted 20 weeks. In the first 6 weeks, participants received 3, 6, or 9 mg cariprazine orally once a day; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this Open-label Phase. At the end of Week 8, participants had to meet the following criteria to continue in the study.

* Positive and Negative Syndrome Scale (PANSS) total score ≤ 60 at the end of Week 8
* At least 20% decrease in PANSS total score from baseline to the end of Week 8
* Clinical Global Impressions - Severity (CGI-S) score ≤ 4 at the end of Week 8
* Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at the end of Week 8
* Stable dose during the previous 2 weeks
* No significant tolerability issues as judged by the Investigator at the end of Week 8

At the end of the Open-label Phase, participants were randomized into 2 treatment groups, cariprazine or placebo, if they met the following criteria:

* PANSS total score ≤ 60 at the end of Week 20
* At least 20% decrease in PANSS total score from baseline to the end of Week 20
* CGI-S score ≤ 4 at the end of Week 20
* Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at the end of Week 20
* No significant tolerability issues as judged by the Investigator During this Double-blind Treatment Phase, participants received either placebo or cariprazine at the same dosage (3, 6, or 9 mg) that they received during the last 14 weeks of the Open-label Phase.

All participants entered the 4 week Safety Follow-up Phase. They received a treatment other than the investigational product at the discretion of the Investigator.

Arms: arm 1: Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase. arm 2: Participants received placebo orally once a day for 26 to 72 weeks. arm 3: Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks
Interventions: intervention 1: Placebo intervention 2: Cariprazine
Intervention descriptions: intervention 1: Placebo was supplied in capsules. intervention 2: Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.

Protocol documents:
Clinical trial NCT01906489
Conditions: Anemia Chronic Kidney Disease
Keywords: anemia chronic kidney disease CKD chronic renal insufficiency renal impairment erythropoietin kidney oral anemia treatment hemoglobin hypoxia-inducible factor HIF hypoxia-inducible factor prolyl-hydroxylase inhibitor HIF-PHI efficacy safety pharmacokinetics
Sponsor: Akebia Therapeutics
Start date: 2013-07-23; Completion date: 2014-09-03
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease (pre-dialysis) with anemia with dosing for 20 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AKB-6548 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral dose administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol. intervention 2: Oral Placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.

Protocol documents:
Clinical trial NCT01987427
Conditions: Chronic Weight Management
Keywords: Overweight Obese Weight Management
Sponsor: Eisai Inc.
Start date: 2013-10-30; Completion date: 2014-09-03
Enrollment: 344 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
APD356-A001-402 is a multicenter, double-blind, randomized, parallel-group pilot study of 12-week duration in overweight and obese adults. Approximately 225 subjects will be randomized to one of three treatment arms in a ratio 1:1:1 and will receive the combinations of lorcaserin 10 mg twice daily (BID) plus immediate-release phentermine-HCl 15 mg BID or 15 mg once daily (QD), or lorcaserin alone.

Detailed description:
All subjects will take lorcaserin and phentermine-HCl/placebo once in the morning and again in the mid-afternoon. The dosing is timed to help reduce potential insomnia due to phentermine. Subjects in Arm A will take one tablet twice daily of lorcaserin 10 mg in combination with one capsule twice daily of phentermine placebo. Subjects in Arm B will take one tablet twice daily of lorcaserin 10 mg, one capsule of phentermine-HCl 15 mg once daily in the morning, and one capsule of phentermine placebo once daily in the mid-afternoon. Subjects in Arm C will take one tablet twice daily of lorcaserin 10 mg in combination with one capsule twice daily of phentermine-HCl 15 mg. Subjects will be instructed to take lorcaserin tablets and phentermine/placebo capsules concurrently and attempt to remain on a consistent daily schedule. The study will recruit obese (body mass index \[BMI\] greater than or equal to 30 kg/m2) subjects with or without a weight-related comorbid condition (e.g., hypertension, dyslipidemia, or sleep apnea) or overweight (BMI greater than or equal to 27 to 29.9 kg/m2) subjects with at least one weight-related co-morbid condition. At least one third of the subjects will have a BMI of 40 kg/m2 or greater, because there is a high likelihood that this combination therapy will be used by these subjects in medical practice.

A lifestyle intervention program, using a 12-week adaptation of the Arena Healthy Lifestyles Program, including diet and exercise counseling, will be implemented for obesity/overweight.

Blood sampling will be performed to evaluate the pharmacokinetics (PK) of lorcaserin and phentermine using population PK modeling as well as the potential relationships between exposure to the lorcaserin/phentermine and measures of safety and change from baseline in body weight, using population PK/PD (pharmacodynamics) modeling.

Arms: arm 1: lorcaserin + phentermine placebo arm 2: lorcaserin + phentermine-HCl + phentermine placebo arm 3: lorcaserin + phentermine-HCl
Interventions: intervention 1: lorcaserin + phentermine placebo intervention 2: lorcaserin + phentermine-HCl + phentermine placebo intervention 3: lorcaserin + phentermine-HCl
Intervention descriptions: intervention 1: lorcaserin 10 mg BID + phentermine placebo BID intervention 2: lorcaserin 10 mg BID + phentermine-HCl 15 mg QD + phentermine placebo QD intervention 3: lorcaserin 10 mg BID + phentermine-HCl 15 mg BID

Protocol documents:
Clinical trial NCT01917656
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2014-01-09; Completion date: 2014-09-04
Enrollment: 343 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa and Asia. The aim of the trial is to investigate the efficacy and safety of liraglutide versus sulphonylurea (SU) both in combination with metformin during Ramadan in subjects with type 2 diabetes (T2DM).

Detailed description:

Arms: arm 1: Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose. arm 2: Subjects continued on pre-trial sulphonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
Interventions: intervention 1: liraglutide intervention 2: metformin intervention 3: sulphonylurea
Intervention descriptions: intervention 1: 1.8 mg administered subcutaneously (s.c., under the skin) once daily intervention 2: Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged intervention 3: Subjects will continue on their pre-trial SU tablet treatment, doses unchanged

Protocol documents:
Clinical trial NCT01349907
Conditions: Bipolar Disorder
Sponsor: Organon and Co
Start date: 2011-06-16; Completion date: 2014-09-05
Enrollment: 322 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate the safety and tolerability of a flexible dosing regimen of asenapine for the long-term treatment of manic or mixed episodes associated with bipolar disorder I in children and adolescents who completed study P06107.

Detailed description:

Arms: arm 1: Participants treated with asenapine in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg twice per day (BID), then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks. arm 2: Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
Interventions: intervention 1: Asenapine intervention 2: Rescue medication
Intervention descriptions: intervention 1: One flavored asenapine sublingual tablet (containing either 2.5, 5 or 10 mg asenapine) twice daily (BID), starting at 2.5 mg on Day 1 for three consecutive days. Normally on Day 4, the dose will increase to 5 mg BID beginning with the evening dose. Normally on Day 7, the dose will increase to 10 mg BID beginning with the evening dose. The dose may be up-titrated earlier than Days 4 and 7 at the investigator's discretion. Beginning on Day 8 (or after at least 1 day on 10 mg BID), asenapine dosing will be flexible (2.5, 5, or 10 mg BID) until up to Week 50. intervention 2: For participants whose symptoms worsen or are not adequately controlled on assigned treatment, rescue medication may be administered during the trial in the following circumstances. For the control of agitation, anxiety, insomnia, restlessness, or akathisia and extrapyramidal symptoms (EPS) some benzodiazepines (i.e., lorazepam \[up to 4 mg/day\] or an equivalent dose of short-acting benzodiazepines) and EPS medications (i.e., anticholinergics) are allowed. Benadryl (diphenhydramine) and beta blockers are also permitted, provided that they are not taken within 8 hours of efficacy assessments.

Protocol documents:
Clinical trial NCT00807911
Conditions: Rectal Cancer
Keywords: rectal cancer adjuvant chemotherapy FOLFOX
Sponsor: Asan Medical Center
Start date: 2008-11-01; Completion date: 2014-09-05
Enrollment: 322 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the disease-free survival in patients with locally advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-FU/Leucovorin vs 5-FU/Leucovorin.

Detailed description:
Preoperative chemoradiotherapy with fluoropyrimidines followed by surgery is one of the standard treatments for patients with locally advanced rectal cancer; however, the role of adjuvant chemotherapy is still controversial. The aim of this study is to investigate the efficacy of adjuvant FOLFOX for rectal cancer who underwent fluoropyrimidine based chemoradiotherapy and complete total mesorectal excision.

Arms: arm 1: FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles) arm 2: FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)
Interventions: intervention 1: Adjuvant FL intervention 2: Adjuvant FOLFOX
Intervention descriptions: intervention 1: 5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles intervention 2: oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles

Protocol documents:
Clinical trial NCT01926509
Conditions: Pulmonary Arterial Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-11-14; Completion date: 2014-09-08
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, and PK of MK-8892 in participants with pulmonary arterial hypertension. The primary hypothesis is that the geometric mean of MK-8892 area under the concentration time-curve from Hour 0 to 24 hours (AUC0-24hr) in participants with PAH, will be equal to or greater than the efficacious exposure in humans of 0.6 μM•hr.

Detailed description:

Arms: arm 1: Participants will be administered MK-8892 once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 3 mg (Days 15-21), 4 mg (Days 22-28). arm 2: Participants will be administered MK-8892 orally, once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 4 mg (Days 15-21), 4 mg (Days 22-28). arm 3: Participants will be administered MK-8892 orally, once daily at following dose levels: 1 mg (Days 1-7), 2 mg (Days 8-14), 4 mg (Days 15-21), up to 8 mg (Days 22-28). arm 4: Participants will be administered placebo to MK-8892 once daily for 28 days.
Interventions: intervention 1: MK-8892 intervention 2: Placebo for MK-8892
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01934647
Conditions: Pulmonary Arterial Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-11-22; Completion date: 2014-09-08
Enrollment: 7 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial will study the safety, tolerability, and pharmacodynamics of single doses of MK-8892 in participants with pulmonary arterial hypertension (PAH). The primary objective is to estimate the measured peak effect of the highest acutely tolerated (HAT) single oral dose of MK-8892 on pulmonary vascular resistance (PVR).

Detailed description:

Arms: arm 1: Participants will receive a single oral dose of 1 mg MK-8892. arm 2: Participants will receive a single oral dose of 4 mg MK-8892. arm 3: Participants will receive a single oral dose of 8 mg MK-8892.
Interventions: intervention 1: MK-8892
Intervention descriptions: intervention 1: Single oral capsule with 1 mg, 4 mg, or 8 mg of MK-8892

Protocol documents:
Clinical trial NCT02058628
Conditions: Acne Vulgaris
Keywords: azelaic acid Clindamycin Benzoyl peroxide Acne vulgaris
Sponsor: GlaxoSmithKline
Start date: 2014-02-21; Completion date: 2014-09-08
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, comparator-controlled, single-blind, parallel-group study. The current study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of facial acne vulgaris. The results of the study will enable a better assessment of the safety and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well established treatment. Based on the data more evidence based recommendations will be possible to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the study will be over 12 weeks.

Detailed description:

Arms: arm 1: A total of 110 subjects will receive clindamycin + BPO once daily in the evening for 12 weeks as per the randomization schedule. arm 2: A total of 110 subjects will receive azelaic acid twice daily (1 in the morning and 1 in the evening) for 12 weeks as per the randomization schedule.
Interventions: intervention 1: Clindamycin + BPO intervention 2: Azelaic acid
Intervention descriptions: intervention 1: Gel containing 1.2% clindamycin and 3% BPO for once daily application intervention 2: Cream containing 20% azelaic acid for twice daily application

Protocol documents:
Clinical trial NCT01617187
Conditions: Schizophrenia
Sponsor: Organon and Co
Start date: 2012-12-04; Completion date: 2014-09-09
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms) as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15 mg orally once daily (QD) was used as an active control. The primary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in the PANSS total score at Day 42. The first key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42.

Detailed description:
The trial consists of a screening/tapering period, treatment period, and follow-up period. The 6-week active treatment period includes an inpatient phase and outpatient phase. Participants who complete the trial may continue treatment under a long-term extension protocol (P05689). Participants who do not continue in the treatment continuation trial (whether they complete the 6-week trial or discontinue prematurely) will have a follow-up visit 7 days after their last dose of trial medication.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Asenapine intervention 2: Placebo Asenapine intervention 3: Olanzapine intervention 4: Placebo Olanzapine
Intervention descriptions: intervention 1: 2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually intervention 2: Fast dissolving placebo asenapine tablets (to match 2.5 mg and 5 mg active asenapine tablets) administered sublingually intervention 3: 5 and 10 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding intervention 4: Film-coated placebo olanzapine tablets (to match 5 and 10 mg active olanzapine tablets) administered orally

Protocol documents:
Clinical trial NCT02078557
Conditions: Pulmonary Hypertension Left Heart Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-05-09; Completion date: 2014-09-10
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess multiple doses of MK-8892 administered to participants with pulmonary hypertension "out of proportion" (PHOOP) and heart failure with reduced left ventricular ejection fraction (rEF). It is hypothesized that generally safe and well tolerated multiple doses of MK-8892 will achieve a true reduction from baseline in pulmonary vascular resistance (PVR) greater than 12%.

Sixteen participants with PHOOP/rEF were to receive multiple doses of MK-8892 titrated to the highest tolerated dose for each participant (up to 4 mg daily), and to undergo evaluation for safety and systemic hemodynamics and cardiac function. Only 4 participants were enrolled and completed the study due to a strategic business decision by the sponsor to terminate the clinical conduct of all MK-8892 ongoing trials including this trial.

Detailed description:

Arms: arm 1: Starting dose of 1 mg daily (oral); the dose may be titrated up on the 8th, 15th, and 22nd day of treatment to 2 mg, 3 mg, or 4 mg, respectively, for the duration of the study (28 days) as tolerated. For participants who reach one or more of the down-dosing criteria, there is an opportunity to decrease the dose back to a previously well-tolerated dose level, or to ½ of the starting dose.
Interventions: intervention 1: MK-8892
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01390428
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-07-28; Completion date: 2014-09-12
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria of the Child-Pugh's scale) with the PK of grazoprevir when administered to healthy participants.

Detailed description:

Arms: arm 1: Participants with mild hepatic impairment will receive 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study. arm 2: Healthy participants will receive 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study. arm 3: Participants with moderate hepatic impairment will receive 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study. arm 4: Healthy participants will receive 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study. arm 5: Participants with severe hepatic impairment will receive 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study. arm 6: Healthy participants will receive 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
Interventions: intervention 1: Grazoprevir
Intervention descriptions: intervention 1: Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily for 10 days

Protocol documents: