Clinical trials: Patient Safety
Type 2 Diabetes Mellitus
Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus
This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin).
- Trial name
- NCT02916706
- Testing
- Teneligliptin 20mg
- Where
- China
- Volunteers
- 254 people
- Sponsor
- Tanabe Pharma Corporation
Epidermolysis Bullosa (EB), Epidermolysis Bullosa Simplex
To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)
A pharmacokinetic (PK) study in 16-20 EB subjects to be allocated to two cohorts. Cohort 1 to include 8-10 subjects (ages 12 yrs and older); Cohort 2 to include 8-10 subjects (ages 6 months-11 yrs, inclusive).
- Conditions
- Epidermolysis Bullosa (EB), Epidermolysis Bullosa Simplex, Dystrophic Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
- Trial name
- NCT03472287
- Testing
- Diacerein 1% Ointment
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Castle Creek Pharmaceuticals, LLC
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B.
- Trial name
- NCT01519921
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 7 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- Hoffmann-La Roche
Epilepsy, Partial Seizures
Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese population with newly or recently diagnosed Epilepsy who…
- Trial name
- NCT01954121
- Testing
- Levetiracetam, Carbamazepine
- Where
- 28 sites in China
- Volunteers
- 436 people
- Sponsor
- UCB Pharma SA
Recurrent Childhood Medulloblastoma
Vismodegib in Treating Younger Patients With Recurrent or Refractory Medulloblastoma
This phase II trial studies how well vismodegib works in treating younger patients with recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells.
- Trial name
- NCT01239316
- Testing
- Laboratory Biomarker Analysis, Pharmacological Study, Vismodegib
- Where
- 12 sites in United States
- Volunteers
- 12 people
- Sponsor
- National Cancer Institute (NCI)
Rheumatoid Arthritis
A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).
This multicenter, open-label, single arm, interventional, long-term extension (LTE) study will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French participants with moderate to severe RA who have…
- Trial name
- NCT01734993
- Testing
- Tocilizumab
- Where
- 6 sites in France
- Volunteers
- 11 people
- Sponsor
- Hoffmann-La Roche
Advanced Solid Malignancies
Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies
This is a modular, Phase I/II, multicentre study to investigate CT7001 monotherapy in advanced solid malignancies and to further investigate CT7001 as monotherapy or in combination with standard therapy in specific participant…
- Trial name
- NCT03363893
- Testing
- CT7001, Fulvestrant
- Where
- 23 sites in United States, United Kingdom
- Volunteers
- 124 people
- Sponsor
- Carrick Therapeutics Limited
Hypercholesterolemia
Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia
The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in participants diagnosed with heterozygous familial hypercholesterolemia (heFH)
- Trial name
- NCT01266876
- Testing
- Alirocumab
- Where
- 22 sites in United States, Canada
- Volunteers
- 77 people
- Sponsor
- Regeneron Pharmaceuticals
Macular Degeneration
Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration
The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety…
- Trial name
- NCT00460408
- Testing
- Macugen
- Where
- 68 sites in Belgium, Cyprus and 11 more
- Volunteers
- 501 people
- Sponsor
- Pfizer
Nasopharyngeal Neoplasms
Safety and Efficacy of CC-486 in Previously Treated Patients With Locally Advanced or Metastatic Nasopharyngeal Carcinoma
The purpose of this study is to evaluate the safety and efficacy of CC-486 in previously treated patients with locally advanced or metastatic nasopharyngeal carcinoma having failed one to two previous regimens, including…
- Trial name
- NCT02269943
- Testing
- CC-486
- Where
- 25 sites in United States, Canada and 7 more
- Volunteers
- 36 people
- Sponsor
- Celgene
Epilepsies, Partial
Open-label Extension to Protocol 1042-0600
To allow open-label extension to patients who have completed Protocol 1042-0600.
- Trial name
- NCT00512317
- Testing
- ganaxolone
- Where
- 25 sites in United States
- Volunteers
- 123 people
- Sponsor
- Marinus Pharmaceuticals
Ischemia-Reperfusion Injury, Kidney Diseases
Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation
The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin is a novel, specific inhibitor of CXCL8.
- Trial name
- NCT00248040
- Testing
- Reparixin continuous infusion, reparixin intermittent infusion
- Where
- 9 sites in United States, France and 2 more
- Volunteers
- 80 people
- Sponsor
- Dompé Farmaceutici S.p.A
Asthma
Efficacy and Safety of 4 Weeks of Treatment With Inhaled BI 1744 CL in Patients With Asthma
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with asthma.
- Trial name
- NCT00467740
- Testing
- BI 1744 CL
- Where
- 37 sites in United States, Canada and 2 more
- Volunteers
- 296 people
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus Type 2
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment…
- Trial name
- GETGOAL-P (NCT00763815)
- Testing
- Lixisenatide (AVE0010), Pen auto-injector, Pioglitazone
- Where
- 150 sites in United States, Austria and 11 more
- Volunteers
- 484 people
- Sponsor
- Sanofi
Myelodysplastic Syndrome (MDS)
Study of Azacitidine to Evaluate Safety and Effectiveness for Chinese Patients With Higher Risk Myelodysplastic Syndrome
The purpose of the study is to determine whether azacitidine is safe and effective in the treatment of Chinese patients with higher risk Myelodysplastic Syndromes (MDS).
- Trial name
- NCT01599325
- Testing
- Azacitidine
- Where
- 11 sites in China
- Volunteers
- 72 people
- Sponsor
- Celgene
Genotype 1 Chronic Hepatitis C
Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
The purpose of this study is to determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in…
- Trial name
- NCT01498068
- Testing
- Telaprevir, Pegylated-interferon-alfa-2a, Ribavirin
- Where
- 5 sites in Russia
- Volunteers
- 36 people
- Sponsor
- Janssen-Cilag International NV
Breast Cancer
A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal…
- Trial name
- NCT00022672
- Testing
- trastuzumab (Herceptin®), anastrazole (Arimidex®)
- Where
- 132 sites in United States, Australia and 24 more
- Volunteers
- 208 people
- Sponsor
- Hoffmann-La Roche
Persistent Asthma
Study of Safety of Foradil in Patients With Persistent Asthma
The purpose of this study was to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and…
- Trial name
- NCT01845025
- Testing
- Formoterol 12 mcg, Fluticasone propionate 100 mcg, Fluticasone propionate 250 mcg
- Where
- 27 sites in United States
- Volunteers
- 827 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment…
- Trial name
- Taski-2 (NCT00665925)
- Testing
- Fostamatinib disodium (R935788)
- Where
- 65 sites in United States, Bulgaria and 4 more
- Volunteers
- 457 people
- Sponsor
- Rigel Pharmaceuticals
Excessive Daytime Sleepiness, Parkinson Disease
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
This phase 2b study is designed as multicentre, multinational, randomized, double blind, parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in subjects with excessive daytime sleepiness with…
- Trial name
- CASPAR (NCT03194217)
- Testing
- BEN-2001
- Where
- United States
- Volunteers
- 244 people
- Sponsor
- BenevolentAI Bio
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