Clinical trials: Medicine Regimen
Rheumatoid Arthritis
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking disease modifying anti-rheumatic drug (DMARD) but not…
- Trial name
- OSKIRA - 2 (NCT01197534)
- Testing
- fostamatinib
- Where
- 149 sites in United States, Canada and 14 more
- Volunteers
- 913 people
- Sponsor
- AstraZeneca
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
Pulmonary TB
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid…
- Trial name
- NCT05221502
- Testing
- Delamanid, Bedaquiline, RHEZ
- Where
- 6 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
ECG, Pharmacokinetics
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory…
- Conditions
- ECG, Pharmacokinetics, Safety
- Trial name
- NCT03727750
- Testing
- Gemtuzumab Ozogamicin
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Kidney Transplantation
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based…
- Trial name
- NCT00282568
- Testing
- Tacrolimus Modified Release (MR), tacrolimus
- Where
- 9 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- Astellas Pharma Inc
de Novo Kidney Transplant Recipients, Renal Transplantation
Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.
This study will compare the following immunosuppressive regimens in recipients of kidney transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and cyclosporine given twice a day with steroid…
- Trial name
- EVIDENCE (NCT01023815)
- Testing
- everolimus, cyclosporine, Prednison (continuous steroids)
- Where
- 28 sites in Italy
- Volunteers
- 330 people
- Sponsor
- Novartis
Chronic Obstructive Pulmonary Disease (COPD)
Evaluation of Tolerability and Pharmacokinetics of Roflumilast, 250μg and 500μg, as add-on to Standard COPD Treatment to Treat Severe COPD
The purpose of this study is to evaluate discontinuation rates of roflumilast using an up-titration regimen for the first 4 weeks of treatment compared with continuous treatment of 500 μg one daily (OD) during the entire 12-week…
- Trial name
- OPTIMIZE (NCT02165826)
- Testing
- Roflumilast, Standard of Care COPD Treatment
- Where
- 2 sites in Slovakia
- Volunteers
- 1,323 people
- Sponsor
- AstraZeneca
Type 2 Diabetes Mellitus
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications
Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in…
- Trial name
- SENIOR (NCT02320721)
- Testing
- Insulin Glargine (HOE901 - U300), Insulin Glargine (HOE901 - U100), Background therapy
- Where
- 162 sites in United States, Argentina and 16 more
- Volunteers
- 1,014 people
- Sponsor
- Sanofi
HIV Infections
'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor
Dolutegravir (DTG) is a well-tolerated 2nd generation integrase strand transfer inhibitor (INSTI); rilpivirine (RPV) is a well-tolerated non- nucleoside reverse transcriptase inhibitors (NNRTI) and lamivudine (3TC) is a…
- Trial name
- NCT04019873
- Testing
- Dolutegravir (DTG), Lamivudine (3TC), Rilpivirine (RPV)
- Where
- Spain
- Volunteers
- 774 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus, HIV Infections
An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)
This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (tenofovir…
- Trial name
- NCT02831764
- Testing
- Dolutegravir (DTG), Lamivudine (3TC), Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC FDC)
- Where
- 105 sites in United States, Argentina and 16 more
- Volunteers
- 722 people
- Sponsor
- ViiV Healthcare
Urothelial Carcinoma, Urothelial Carcinoma Bladder
A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma
The study will evaluate the clinical activity of PD-(L)1 Checkpoint Inhibitor regimens in combination with the investigational agent sitravatinib in patients with advanced or metastatic urothelial carcinoma.
- Conditions
- Urothelial Carcinoma, Urothelial Carcinoma Bladder, Urothelial Carcinoma Ureter, Urothelial Carcinoma of the Renal Pelvis and Ureter
- Trial name
- NCT03606174
- Testing
- Sitravatinib, Nivolumab, Pembrolizumab
- Where
- 36 sites in United States
- Volunteers
- 260 people
- Sponsor
- Mirati Therapeutics Inc.
Tuberculosis
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
- Trial name
- NCT00910871
- Testing
- TMC207, Background Regimen (BR) for MDR-TB
- Where
- 27 sites in China, Estonia and 10 more
- Volunteers
- 241 people
- Sponsor
- Janssen Infectious Diseases BVBA
Crohn's Disease
Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease
The purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing…
- Trial name
- ENTERPRISE (NCT02630966)
- Testing
- Vedolizumab
- Where
- 18 sites in United States, Canada and 5 more
- Volunteers
- 34 people
- Sponsor
- Takeda
Diabetes, Diabetes Mellitus, Type 2
Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen
This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.
- Trial name
- Full STEP™ (NCT01165684)
- Testing
- insulin aspart, insulin detemir
- Where
- 67 sites in United States, Argentina and 5 more
- Volunteers
- 401 people
- Sponsor
- Novo Nordisk A/S
Mycobacterium Infections, Nontuberculous
Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) 590 mg administered once daily (QD) when added to multi-drug regimen (MDR) in participants with Nontuberculous Mycobacterial (NTM) lung infection…
- Trial name
- CONVERT (NCT02344004)
- Testing
- LAI (Liposomal Amikacin for Inhalation) 590 mg
- Volunteers
- 336 people
- Sponsor
- Insmed Incorporated
HIV Infections
Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-1)
The aim of this study was to determine if virologically suppressed human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a…
- Trial name
- NCT02429791
- Testing
- DTG 50 mg, RPV 25 mg, CAR
- Where
- 65 sites in United States, Argentina and 11 more
- Volunteers
- 510 people
- Sponsor
- ViiV Healthcare
Invasive Candidiasis
A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)
Comparison of the safety and effectiveness of standard drug dosing versus a daily dose 3 times higher than the standard dose in patients with invasive candidiasis (bloodstream and/or systemic yeast infections)
- Trial name
- NCT00250432
- Testing
- caspofungin acetate
- Volunteers
- 204 people
- Sponsor
- Merck Sharp & Dohme LLC
Multiple Myeloma
Study of Oral Ixazomib in Combination With Melphalan and Prednisone in Participants With Newly Diagnosed Multiple Myeloma
The purpose of this phase 1/2, open-label study was to evaluate the effect of oral formulation of Ixazomib when added to standard melphalan and prednisone (MP) treatment.
- Trial name
- NCT01335685
- Testing
- Ixazomib, Melphalan, Prednisone
- Where
- 20 sites in United States, Canada and 3 more
- Volunteers
- 61 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Hypogonadotropic Hypogonadism
A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism
The purpose of this study is to evaluate the effects on serum testosterone after 4 weeks of subcutaneous (SC) dose administration, with different doses and dosing frequencies of TAK-448 to overweight/obese males with…
- Trial name
- NCT02369796
- Testing
- TAK-448
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Takeda
HIV Infections
Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents
First-line antiretroviral regimens are highly efficacious and generally well tolerated. However, as these regimens need to be taken life-long, there is growing concern about long-term toxicities associated with these regimens.
- Trial name
- NCT03682848
- Testing
- DTG + 3TC FDC
- Where
- 8 sites in Kenya, South Africa and 1 more
- Volunteers
- 32 people
- Sponsor
- ViiV Healthcare