ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01703221
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-10-24; Completion date: 2014-04-25
Enrollment: 414 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1) Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.

Detailed description:
The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). Participants will receive in Phase A: omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo and in Phase B: omarigliptin 25 mg once weekly.

Arms: arm 1: Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B) arm 2: Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B) arm 3: Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
Interventions: intervention 1: Omarigliptin intervention 2: Sitagliptin intervention 3: Placebo to omarigliptin intervention 4: Placebo to sitagliptin
Intervention descriptions: intervention 1: Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly intervention 2: Sitagliptin 50 mg tablet administered orally once daily intervention 3: Placebo to omarigliptin 25 mg capsule administered orally once weekly intervention 4: Placebo to sitagliptin 50 mg tablet administered orally once daily

Protocol documents:
Clinical trial NCT01971554
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-10-14; Completion date: 2014-04-26
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-8666 in participants with type 2 diabetes mellitus (T2DM). Participants enrolled in this trial would be either treatment-naive or have washed off of oral anti-hyperglycemic agents. MK-8666 is planned to be administered orally for up to 2 weeks. The primary hypothesis for this study is that after 14 days of once daily treatment with MK-8666, at a dose that is safe and well tolerated, the placebo-corrected fasting plasma glucose reduction from baseline is ≥34 mg/dL.

Detailed description:

Arms: arm 1: MK-8666, 50 mg, oral, once a day (QD) for Days 1 to 14. arm 2: MK-8666, 150 mg, oral, QD, for Days 1 to 14 arm 3: MK-8666, 500 mg, oral, QD for Days 1 to 14 arm 4: Placebo, oral, QD for Days 1 to 14
Interventions: intervention 1: MK-8666 intervention 2: Placebo
Intervention descriptions: intervention 1: MK-8666, capsules, oral, QD, Days 1 to 14 intervention 2: Placebo, capsules, oral, QD, Days 1 to 14

Protocol documents:
Clinical trial NCT01557504
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-07-18; Completion date: 2014-04-29
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess:

1. the safety and tolerability of two sitagliptin 50 mg/metformin 1000 mg XR tablets in pediatric participants with type 2 diabetes mellitus (T2DM), aged 10 to 17 years
2. the ability of pediatric participants with T2DM, aged 10 to 17 years, to swallow two sitagliptin 50 mg/metformin 1000 mg XR tablets or two matching placebo tablets (excluding marking)
3. the pharmacokinetics of sitagliptin and metformin following the administration of two sitagliptin 50 mg/metformin 1000 mg XR tablets to pediatric participants with T2DM, aged 10 to 17 years.

Detailed description:

Arms: arm 1: Day 1 (Period 1): participants will receive a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants will receive a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants will receive a single dose of two matching placebo tablets with the evening meal. arm 2: Days 1-4 (Period 1): participants will receive a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants will receive a single dose of two matching placebo tablets with the evening meal.
Interventions: intervention 1: Sitagliptin/metformin XR intervention 2: Placebo intervention 3: Metformin intervention 4: Thyroid hormone
Intervention descriptions: intervention 1: Fixed dose combination tablet of immediate-release sitagliptin 50 mg and extended-release (XR) metformin 1000 mg (total daily dose, sitagliptin 100 mg and metformin XR 2000 mg). intervention 2: Matching placebo to fixed dose combination tablet of sitagliptin and metformin. Matching placebo tablets are same size, shape and color as the active product, but do not contain any markings. intervention 3: Concomitant use of metformin is permitted during the study provided the participant has been receiving a stable metformin dose for at least 12 weeks prior to the dose of study drug. Administration of metformin will be withheld for 24 hours prior to study drug administration and for 24 hours postdose. intervention 4: Concomitant use of thyroid hormone (eg, levothyroxine) is permitted during the study provided the participant has been receiving a stable dose for at least 12 weeks prior to study drug administration and is euthyroid as documented by thyroid stimulating hormone testing at prestudy. Administration of thyroid hormone will be withheld for 24 hours prior to study drug administration and for 24 hours postdose.

Protocol documents:
Clinical trial NCT01995838
Conditions: Chronic Insomnia Adults Elderly
Keywords: Chronic Insomnia Adults Elderly
Sponsor: Eisai Inc.
Start date: 2013-11-13; Completion date: 2014-04-29
Enrollment: 291 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, parallel-group, Bayesian adaptive, dose response study in subjects with chronic insomnia. Subjects will be randomized to 1 of 6 doses of E2006 (1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25 mg) or placebo.

Detailed description:
The study will have 2 phases, Prerandomization and Randomization. The Prerandomization Phase will last up to 21 days and will consist of a Screening Period (Days -21 to -2) and a Baseline Period (Day -1). Following the Baseline Period, all eligible subjects will be randomized, in a double-blind manner, to receive E2006 or placebo for 15 nights during the Treatment Period (Days 1 to 15), then all subjects will receive placebo, in a single-blind manner, for 2 nights (Days 16 to 17) during the Rebound Insomnia Assessment Period (Days 16 to 18). Subjects will not receive any treatment during the Follow-up Period (Days 19 to 29). All subjects will come to the clinic for screening procedures. During the Screening Period, subjects will complete the Sleep Diary each day. Polysomnographic sleep will be measured during the Screening Period on 2 consecutive nights between Day -9 and Day -3. These 8-hour polysomnograms (PSGs) will start at the median habitual bedtime calculated from responses on the Sleep Diary completed 7 days immediately prior to the first PSG night. Subjects may leave the clinic between the screening/baseline PSG nights.

Arms: arm 1: E2006 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25 mg, in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights arm 2: E2006-matched placebo in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights
Interventions: intervention 1: E2006 intervention 2: Placebo
Intervention descriptions: intervention 1: E2006 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25 mg, in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights intervention 2: E2006-matched placebo in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights

Protocol documents:
Clinical trial NCT01277510
Conditions: Chronic Kidney Disease Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Disease Secondary Hyperparathyroidism
Keywords: dialysis sensipar mimpara hemodialysis peritoneal dialysis renal parathyroid hormone pediatric
Sponsor: Amgen
Start date: 2011-06-28; Completion date: 2014-04-30
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.

Detailed description:
Secondary hyperparathyroidism (SHPT) is a condition that can develop early in patients with chronic kidney disease (CKD), usually gets worse over time, and is known to cause problems for patients on dialysis. Children on dialysis can have a wide range of bone and growth issues, and common treatments have a chance of making these things worse by increasing serum calcium and serum phosphorus. Cinacalcet has been shown to be effective in controlling parathyroid hormone (PTH), calcium and phosphorus in adults. The purpose of this study is to show that including cinacalcet in the treatment of SHPT will lower the levels of intact parathyroid hormone (iPTH) in a larger number of pediatric patients with CKD who are receiving dialysis, compared to a treatment regimen that does not include cinacalcet.

Arms: arm 1: Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg. arm 2: Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks.
Interventions: intervention 1: cinacalcet capsule intervention 2: placebo intervention 3: Standard of Care
Intervention descriptions: intervention 1: Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing. intervention 2: Placebo tablets and capsules for sprinkling identical to active treatment. intervention 3: All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.

Protocol documents:
Clinical trial NCT00879086
Conditions: Breast Cancer
Keywords: Breast Cancer Oncology
Sponsor: Eisai Inc.
Start date: 2009-03-31; Completion date: 2014-04-30
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) grading.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Eribulin Mesylate intervention 2: Ixabepilone
Intervention descriptions: intervention 1: E7389 (eribulin mesylate) given at a dose of 1.4 mg/m\^2 as a 2 to 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle.

The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment. intervention 2: Ixabepilone given at a starting dose of 32 or 40 mg/m\^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle.

The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.

Protocol documents:
Clinical trial NCT01397409
Conditions: Age-related Macular Degeneration
Sponsor: Allergan
Start date: 2011-09-01; Completion date: 2014-04-30
Enrollment: 271 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.

Detailed description:

Arms: arm 1: Stage 1: AGN-150998 4.2.mg given as a single intravitreal injection. arm 2: Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection. arm 3: Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection. arm 4: Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection. arm 5: Stage 2: AGN-150998 4,2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. arm 6: Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose) from Stage 1 given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. arm 7: Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. arm 8: Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16. arm 9: Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16. arm 10: Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
Interventions: intervention 1: AGN-150998 intervention 2: ranibizumab intervention 3: Sham Injection
Intervention descriptions: intervention 1: AGN-150998 Intravitreal injection. intervention 2: Ranibizumab 0.5 mg given by intravitreal injection. intervention 3: Stage 3: Sham injection at Weeks 12 and 16.

Protocol documents:
Clinical trial NCT01485172
Conditions: Parkinson Disease
Sponsor: GlaxoSmithKline
Start date: 2012-01-31; Completion date: 2014-04-30
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is a fixed dose, dose response study to characterize the dose response for ropinirole PR in early stage PD patients (Hoehn \& Yahr stages I-III). After screening and baseline assessments, subjects will be randomized to one of six final target treatment groups (placebo, 2, 4, 8, 12 or 24mg/day ropinirole PR). The study will consist of a screening period, an up-titration period, a maintenance period, a down titration period and a follow up period. This study utilizes change from baseline in the UPDRS motor score as the primary endpoint, in line with that used in the ropinirole PR monotherapy pivotal study (SK\&F101468/168). Clinical review of the primary and secondary endpoints will be performed in order to establish the lowest maximally effective therapeutic dose.

Detailed description:

Arms: arm 1: ropinirole 2, 4, 8, 12, or 24 mg/day arm 2: placebo comparator 2, 4, 8, 12, or 24 mg/day
Interventions: intervention 1: ropinirole monotherapy intervention 2: placebo monotherapy
Intervention descriptions: intervention 1: ropinirole as monotherapy in Parkinson's disease intervention 2: placebo as monotherapy in Parkinson's disease

Protocol documents:
Clinical trial NCT00449865
Conditions: Parkinson's Disease
Keywords: Parkinson's disease creatine NET-PD neuroprotection PD
Sponsor: University of Rochester
Start date: 2007-03-01; Completion date: 2014-05-01
Enrollment: 1741 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to determine if the nutritional supplement creatine slows the progression of Parkinson's disease over time.

Detailed description:
Parkinson's disease (PD) affects nearly a million Americans, a number that will increase over the coming decades as the population ages. Symptoms of PD may include tremor, rigidity or stiffness of the limbs and trunk, slowness of movement, and impaired balance and coordination. These problems occur because as PD worsens, some of the brain cells that control body movement die.

This study will determine if creatine--an investigational compound--is able to slow the progression of PD. Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.

In the NET-PD LS-1 study, 1,720 participants will be randomly assigned to receive either creatine or a placebo (inactive substance). Participation in this study lasts a minimum of 5 years and includes at least 9 follow-up clinic visits and at least 3 telephone calls.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: creatine intervention 2: placebo
Intervention descriptions: intervention 1: Creatine, a widely used dietary supplement is thought to improve exercise performance. In animal models and human studies, creatine has been shown to be well tolerated and may have some ability to protect brain cells.

The study is comparing creatine 5 grams twice daily with placebo. intervention 2: an inactive substance

Protocol documents:
Clinical trial NCT01035255
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: chronic heart failure cardiovascular death hospitalization outcome study BNP KCCQ eGFR
Sponsor: Novartis Pharmaceuticals
Start date: 2009-12-01; Completion date: 2014-05-01
Enrollment: 8442 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =\< 35%).

Detailed description:

Arms: arm 1: single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period arm 2: single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
Interventions: intervention 1: LCZ696 200 mg BID intervention 2: Enalapril 10 mg BID
Intervention descriptions: intervention 1: LCZ696 200 mg BID intervention 2: Enalapril 10 mg BID

Protocol documents:
Clinical trial NCT01609582
Conditions: Type 2 Diabetes Cardiovascular Disease
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2012-06-01; Completion date: 2014-05-01
Enrollment: 3207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite events exists following long term treatment with TAK-875 compared with placebo.

Detailed description:
The drug being tested in this study is called TAK-875. TAK-875 is being tested to treat people who have diabetes. This study will look at the number of cardiovascular events (for example, heart attacks) of people who take TAK-875 in comparison to placebo in addition to standard care.

The study will enroll approximately 5000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* TAK-875 50 mg.
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.

All participants will be asked to take one tablet at the same time each day throughout the study. All participants will be asked to record any time they have low blood sugar symptoms in a diary.

This multi-centre trial will be conducted worldwide, in approximately 700 sites. The overall time to participate in this study is 6 years. Participants will make up to approximately 24 visits to the clinic, with telephone visits conducted on an alternate 6 month schedule starting from Month 27.

Due to potential concerns about liver safety, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks.

For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.

Arms: arm 1: TAK-875 50 mg tablets, orally, once daily for up to 6 years. arm 2: TAK-875 placebo-matching tablets, orally, once daily for up to 6 years.
Interventions: intervention 1: TAK-875 intervention 2: TAK-875 Placebo
Intervention descriptions: intervention 1: TAK-875 tablets intervention 2: TAK-875 placebo-matching tablets

Protocol documents:
Clinical trial NCT01837797
Conditions: Major Depressive Disorder
Sponsor: H. Lundbeck A/S
Start date: 2013-04-01; Completion date: 2014-05-01
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)

Detailed description:

Arms: arm 1: Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT) arm 2: Brexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week followed by 1 mg/day. arm 3: Brexpiprazole adjunct to open-label treatment with a commercially available ADT. Brexpiprazole dosing was 0.5 mg/day in the first 1 week, 1 mg/day in the second week, followed by 3 mg/day.
Interventions: intervention 1: Placebo intervention 2: Brexpiprazole 1 mg intervention 3: Brexpiprazole 3 mg
Intervention descriptions: intervention 1: Once daily, tablets, orally intervention 2: once daily dose, tablets, orally intervention 3: once daily dose, tablets, orally

Protocol documents: