Clinical trials: Medication Safety
Ovarian Cancer, Fallopian Tube Cancer
Japan Phase 2 Study of Niraparib in Participants With Advanced, Relapsed Ovarian Cancer
The purpose of this study is to evaluate the safety and efficacy of niraparib in participants with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4…
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- NCT03759600
- Testing
- Niraparib
- Where
- 33 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Takeda
Area Under Curve, Pharmacokinetics
The Safety and Pharmacokinetics of Primapur and Gonal-f
The purpose of the current phase I study was to establish bioequivalence, safety, and tolerance of single 300 IU subcutaneous dose of follitropin alfa biosimilar (Primapur) in comparison to that of reference follitropin alfa…
- Conditions
- Area Under Curve, Pharmacokinetics, Absorption
- Trial name
- NCT03857230
- Testing
- Follitropin alfa (Primapur), Follitropin alfa (Gonal-F)
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IVFarma LLC
Dengue Fever
Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 Years
The purpose of the study is to demonstrate the non-inferiority (NI) of the immune response to 2 doses of 9vHPV vaccine, 1 co-administered with TDV, compared with 2 doses of 9vHPV vaccine administered alone.
- Trial name
- NCT04313244
- Testing
- 9vHPV Vaccine, Dengue Tetravalent Vaccine (TDV)
- Where
- 4 sites in Thailand
- Volunteers
- 614 people, healthy volunteers welcome
- Sponsor
- Takeda
Dose Finding Study
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of ENV8058 (TAK-058) in Healthy Participants
The purpose of this study is to characterize the safety and tolerability profile of escalating dose levels of ENV8058 (TAK-058) solution when administered as a single oral dose in healthy adults.
- Trial name
- NCT02153099
- Testing
- TAK-058 (ENV8058)
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Takeda
Neoplasms, Breast Neoplasms
This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer
This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: Xentuzumab in combination with abemaciclib Xentuzumab in combination with abemaciclib and hormonal therapies…
- Trial name
- NCT03099174
- Testing
- Xentuzumab, Abemaciclib, Letrozole
- Where
- 30 sites in United States, Denmark and 5 more
- Volunteers
- 133 people
- Sponsor
- Boehringer Ingelheim
Mental Health Issue, Depressive Symptoms
Piloting +Connection is Medicine / The Healing Spirits Program
This study aims to assess what benefit, if any, an individualized coping plan and facilitating connections to care through referral coordination in conjunction with culturally tailored caring messages, (herein called the…
- Conditions
- Mental Health Issue, Depressive Symptoms, Anxiety
- Trial name
- NCT05424679
- Testing
- Safety Planning Intervention, Caring Contacts
- Where
- 4 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Rheumatoid Arthritis
Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy
This observational study will evaluate the safety, tolerability and efficacy of tocilizumab in participants with moderate to severe RA who have an inadequate response to current non-biologic DMARD and/or anti-TNF therapy.
- Trial name
- NCT01362062
- Testing
- Tocilizumab
- Where
- 7 sites in India
- Volunteers
- 110 people
- Sponsor
- Hoffmann-La Roche
Depressive Disorder, Major
Efficacy and Safety Study of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder
The purpose of this study is to evaluate the efficacy of vortioxetine, once daily (QD), compared with placebo in adults with major depressive disorder.
- Trial name
- NCT01163266
- Testing
- Vortioxetine
- Where
- 39 sites in United States
- Volunteers
- 462 people
- Sponsor
- Takeda
Cerebrovascular Accident
JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme
Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twice daily vs.
- Trial name
- NCT00311402
- Testing
- Aggrenox capsule, Acetylsalicylic Acid (ASA)
- Where
- 151 sites in Japan
- Volunteers
- 1,295 people
- Sponsor
- Boehringer Ingelheim
HIV Infections
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)
This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral resistance.
- Trial name
- NCT00293254
- Testing
- raltegravir potassium
- Volunteers
- 351 people
- Sponsor
- Merck Sharp & Dohme LLC
In Vitro Fertilization
Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)
The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH…
- Trial name
- Trust (NCT00696878)
- Testing
- Corifollitropin alfa, FSH, GnRH antagonist
- Volunteers
- 682 people
- Sponsor
- Organon and Co
HIV-1-infection
Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine
The current study proposal is an open label observational trial for maintenance of virologic suppression, and is designed as a non- inferiority switch trial.
- Trial name
- NCT04538040
- Testing
- Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Quest Clinical Research
Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection
A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.
- Conditions
- Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis and Non-cirrhotics
- Trial name
- EXPEDITION-2 (NCT02738138)
- Testing
- ABT-493 coformulated with ABT-530
- Volunteers
- 153 people
- Sponsor
- AbbVie
Thromboembolism
Self-management of Low Molecular Weight Heparin Therapy
There is very little data available on compliance with self-injected low molecular weight heparins (LMWH), but what there is, definitely shows that compliance represents a significant problem.
- Trial name
- NCT00794560
- Testing
- patient education
- Where
- 2 sites in Switzerland
- Volunteers
- 154 people
- Sponsor
- University Hospital, Basel, Switzerland
Type 2 Diabetes Mellitus
Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy
The purpose of this study was to evaluate the efficacy and safety of 24-week treatment with metformin hydrochloride 500 mg once daily added on to alogliptin (SYR-322) 25 mg in type 2 diabetic patients with inadequate glycemic…
- Trial name
- NCT02068443
- Testing
- Alogliptin, Metformin hydrochloride
- Where
- 27 sites in Japan
- Volunteers
- 374 people
- Sponsor
- Takeda
Chronic Hepatitis C Infection
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before
This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.
- Trial name
- MALACHITE 1 (NCT01854697)
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin, Telaprevir
- Volunteers
- 311 people
- Sponsor
- AbbVie
Diabetes Mellitus, Type 2
Efficacy and Safety of Empagliflozin (BI 10773) Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes
The aim of this study is to investigate the efficacy, safety and tolerability of BI 10773 compared to placebo and sitagliptin given for 24 weeks as monotherapy in patients with T2DM with insufficient glycaemic control.
- Trial name
- NCT01177813
- Testing
- BI 10773, BI 10773 open label
- Where
- 124 sites in United States, Belgium and 7 more
- Volunteers
- 986 people
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to…
- Trial name
- TIDES (NCT02747927)
- Testing
- Tetravalent Dengue Vaccine (TDV)
- Where
- 28 sites in Brazil, Colombia and 6 more
- Volunteers
- 20,099 people, healthy volunteers welcome
- Sponsor
- Takeda
Gastric Ulcer, Duodenal Ulcer
Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily…
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis
- Trial name
- NCT00595517
- Testing
- Esomeprazole 20 mg
- Where
- 3 sites in Japan
- Volunteers
- 395 people
- Sponsor
- AstraZeneca
Vasomotor Symptoms (VMS)
Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen
Open-label, two dose study of Q-122, over a 4 week treatment period to explore the effects of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or tamoxifen.
- Trial name
- NCT04080297
- Testing
- oral capsule of Q-122
- Volunteers
- 21 people
- Sponsor
- Que Oncology
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