Clinical trials: Medication Safety
Psoriatic Arthritis
Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs.
- Trial name
- PALACE4 (NCT01307423)
- Testing
- Apremilast 20mg, Apremilast 30mg
- Where
- 118 sites in United States, Australia and 16 more
- Volunteers
- 529 people
- Sponsor
- Amgen
Type 2 Diabetes Mellitus
Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on study.
- Trial name
- NCT01318122
- Testing
- Alogliptin and pioglitazone
- Volunteers
- 336 people
- Sponsor
- Takeda
Solid Tumors
An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or…
- Trial name
- NCT02598960
- Testing
- BMS-986156, Nivolumab
- Where
- 27 sites in United States, Australia and 8 more
- Volunteers
- 295 people
- Sponsor
- Bristol-Myers Squibb
Drug-Resistant Epilepsy, Focal-Onset Seizures
Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.
- Trial name
- NCT03370120
- Testing
- Padsevonil
- Where
- 156 sites in United States, Australia and 25 more
- Volunteers
- 406 people
- Sponsor
- UCB Biopharma SRL
Diabetes Mellitus
Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.
The purpose of this study is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with…
- Trial name
- NCT00755846
- Testing
- Alogliptin
- Volunteers
- 265 people
- Sponsor
- Takeda
Type 2 Diabetes Mellitus
Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.
The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.
- Trial name
- NCT00328627
- Testing
- Alogliptin, Pioglitazone
- Where
- 90 sites in United States, Australia and 17 more
- Volunteers
- 1,554 people
- Sponsor
- Takeda
Type 2 Diabetes
A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an ACEI or ARB and an Additional Antihypertensive Medication
The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an Angiotensin-converting…
- Trial name
- NCT01195662
- Testing
- Dapagliflozin
- Where
- 298 sites in United States, Australia and 14 more
- Volunteers
- 2,245 people
- Sponsor
- AstraZeneca
Type 2 Diabetes
A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone.
- Trial name
- NCT00528879
- Testing
- Dapagliflozin, Metformin
- Where
- 75 sites in United States, Argentina and 3 more
- Volunteers
- 915 people
- Sponsor
- AstraZeneca
Hepatitis C
Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to…
- Trial name
- NCT01637922
- Testing
- BI 201335
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Boehringer Ingelheim
Epilepsy
A Long-term, Safety, Tolerability, and Efficacy Study of Retigabine Immediate-release (IR) in Asian Adults With Partial Onset Seizures
This is a multicentre, long-term, open-label extension (OLE) study to assess the long-term safety, tolerability and efficacy of retigabine immediate-release (IR) as adjunctive therapy in adult Asian subjects with drug-resistant…
- Trial name
- NCT01777139
- Testing
- Retigabine IR
- Where
- 12 sites in Malaysia, South Korea and 1 more
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Hyperlipidemia
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density…
- Trial name
- MENDEL-2 (NCT01763827)
- Testing
- Evolocumab, Ezetimibe
- Where
- 83 sites in United States, Australia and 8 more
- Volunteers
- 615 people
- Sponsor
- Amgen
Psoriasis, Arthritic
A Study of Ixekizumab in Participants With Active Psoriatic Arthritis
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.
- Trial name
- SPIRIT-P1 (NCT01695239)
- Testing
- Ixekizumab, Adalimumab
- Where
- 116 sites in United States, Belgium and 13 more
- Volunteers
- 417 people
- Sponsor
- Eli Lilly and Company
Tardive Dyskinesia
Reducing Involuntary Movements in Participants With Tardive Dyskinesia
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia.
- Trial name
- RIM-TD (NCT02198794)
- Testing
- SD-809
- Where
- 82 sites in United States, Czechia and 4 more
- Volunteers
- 343 people
- Sponsor
- Auspex Pharmaceuticals, Inc.
Carcinoid Syndrome
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome
The purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.
- Trial name
- NCT01104415
- Testing
- Telotristat etiprate
- Where
- 10 sites in Germany, United Kingdom
- Volunteers
- 15 people
- Sponsor
- Lexicon Pharmaceuticals
Tuberculosis
A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.
The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment.
- Trial name
- NC-005 (NCT02193776)
- Testing
- PA-824, bedaquiline, moxifloxacin
- Where
- 10 sites in South Africa, Tanzania and 1 more
- Volunteers
- 240 people
- Sponsor
- Global Alliance for TB Drug Development
Crohn's Disease
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration…
- Trial name
- NCT02611817
- Testing
- Vedolizumab SC 108 mg, Vedolizumab IV 300 mg
- Where
- 194 sites in United States, Australia and 28 more
- Volunteers
- 644 people
- Sponsor
- Takeda
Arthritis, Rheumatoid
A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.
- Trial name
- NCT00847613
- Testing
- CP-690,550
- Where
- 115 sites in United States, Australia and 13 more
- Volunteers
- 800 people
- Sponsor
- Pfizer
Hypertension
Open Label Study Telmisartan and Amlodipine in Hypertension
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label…
- Trial name
- NCT00614380
- Testing
- telmisartan/amlodipine 40/5 mg fixed combination, telmisartan/amlodipine 80/5 mg fixed combination
- Where
- 122 sites in Belgium, Canada and 10 more
- Volunteers
- 976 people
- Sponsor
- Boehringer Ingelheim
Infection, Human Immunodeficiency Virus, HIV Infections
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years…
- Trial name
- NCT00071760
- Testing
- GW433908, ritonavir
- Where
- 15 sites in United States, Argentina and 5 more
- Volunteers
- 59 people
- Sponsor
- ViiV Healthcare
Osteoporosis
Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice
This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice…
- Trial name
- NCT01793142
- Testing
- Viviant
- Where
- 60 sites in South Korea
- Volunteers
- 3,430 people
- Sponsor
- Pfizer
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