Clinical trials: Pharmacological Action
Stroke, Acute
The Intravascular Cooling in the Treatment of Stroke 2/3 Trial
The purpose of this trial is to determine whether the combination of thrombolysis and hypothermia is superior to thrombolysis alone for the treatment of acute ischemic stroke.
- Trial name
- ICTuS2/3 (NCT01123161)
- Testing
- hypothermia and anti-shivering treatment, Group1: IV t-PA and normothermia
- Where
- 31 sites in United States, Austria and 1 more
- Volunteers
- 120 people
- Sponsor
- University of California, San Diego
Hepatitis C
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2…
- Trial name
- NCT01808248
- Testing
- SOF, PEG, RBV
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Gilead Sciences
Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
BEAM vs. 90-Yttrium Ibritumomab Tiuxetan (Zevalin®)/BEAM With ASCT for Relapsed DLBCL
This randomized phase III trial studies 90-yttrium ibritumomab tiuxetan and combination chemotherapy compared with combination chemotherapy alone before stem cell transplant in treating patients with diffuse large b-cell…
- Trial name
- SPINOZA (NCT02366663)
- Testing
- 90-Yttrium Ibritumomab tiuxetan, Carmustine, Etoposide
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- City of Hope Medical Center
Age Related Macular Degeneration, Choroidal Neovascular Membrane
A Study of Intravitreal Injections of 2.0mg Ranibizumab in Subjects With Chronic Fluid On OCT Post Multiple Injections With Ranibizumab (Super-dose Anti-VEgf SAVE Trial)
The purpose of this study is to determine whether 2.0mg Ranibizumab is effective in the treatment of recurrent fluid.
- Conditions
- Age Related Macular Degeneration, Choroidal Neovascular Membrane, Subfoveal Neovascular Age-Related Macular Degeneration, Macular Degeneration
- Trial name
- SAVE (NCT01025232)
- Testing
- Ranibizumab
- Where
- 2 sites in United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- David M. Brown, M.D.
Viral Infection
Safety and Pharmacokinetics of UV-4B Solution Administered Orally as Multiple Ascending Doses to Healthy Subjects
The purpose of this study is to evaluate the safety and pharmacokinetics of UV-4B oral solution when administered to healthy subjects three times a day (TID) for 7 days.
- Trial name
- NCT02696291
- Testing
- UV-4B 30 mg oral solution, UV-4B 75 mg oral solution, UV-4B 150 mg oral solution
- Where
- 2 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
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
Diabetic Macular Edema
Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema
The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis®…
- Trial name
- OXEYE (NCT05697809)
- Testing
- OXU-001, Semi-automated suprachoroidal illuminated microcatheter, Ozurdex® Ophthalmic Intravitreal Implant
- Where
- 9 sites in United States, Puerto Rico
- Volunteers
- 3 people
- Sponsor
- Oxular Limited
Oestrogen Receptor Positive Advanced Breast Cancer
An Open Label Study of Postmenopausal Women With Oestrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Treated With Everolimus (RAD001) With Exemestane, With Exploratory Epigenetic Marker Analysis
Determine the overall response rate (ORR) at 48 weeks to everolimus (RAD001, 10mg daily p.o.) and exemestane (25mg daily p.o.) treatment in postmenopausal women with oestrogen receptor positive breast cancer who have previous…
- Trial name
- 4EVERUK (NCT01743560)
- Testing
- RAD001, Exemestane
- Where
- 11 sites in United Kingdom
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Hepatocellular Carcinoma
Study of ThermoDox With Standardized Radiofrequency Ablation (RFA) for Treatment of Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when used in conjunction with standardized…
- Trial name
- OPTIMA (NCT02112656)
- Testing
- ThermoDox, Dummy infusion
- Where
- 61 sites in United States, Canada and 12 more
- Volunteers
- 554 people
- Sponsor
- Imunon
Diabetes Mellitus
A Study of the Safety and Efficacy of Omarigliptin (MK-3102) in ≥18 and <45 Year-Old Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028)
This study will examine the safety and efficacy of once-weekly omarigliptin in participants 18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control.
- Trial name
- NCT01814748
- Testing
- Omarigliptin, Metformin
- Volunteers
- 203 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
Modulation of Breast Cancer Risk Biomarkers by High Dose Vitamin D
The overall goal of this project is to determine if high dose vitamin D3 given to premenopausal women at high risk for development of breast cancer, who initially have insufficient levels of 25-hydroxy vitamin D (<30 ng/ml), will…
- Trial name
- NCT01166763
- Testing
- vitamin D3
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Carol Fabian, MD
Coronary Artery Disease, Myocardial Ischemia
Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent
The purpose of the study is to demonstrate that Custodiol-HTK is not inferior to cold cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic arrest.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases
- Trial name
- NCT01681095
- Testing
- Custodiol HTK, Cold Blood Cardioplegia
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Marc Sakwa, MD
Falciparum Malaria
Efficacy of ArTiMist™ in Children
The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with…
- Trial name
- NCT01047436
- Testing
- Quinine, Artemether
- Volunteers
- 31 people
- Sponsor
- Proto Pharma Ltd
Degenerative Disc Disease
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in…
- Trial name
- MSB-DR003 (NCT02412735)
- Testing
- Rexlemestrocel-L, Rexlemestrocel-L + HA Mixture
- Where
- 48 sites in United States, Australia
- Volunteers
- 404 people
- Sponsor
- Mesoblast, Ltd.
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
Alcohol Dependence
Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence
The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with alcohol dependence.
- Trial name
- SENSE (NCT00811941)
- Testing
- Nalmefene
- Where
- 60 sites in Czechia, Estonia and 8 more
- Volunteers
- 665 people
- Sponsor
- H. Lundbeck A/S
Ulcerative Colitis
Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following…
- Trial name
- NCT04071405
- Testing
- Non-intervention
- Where
- South Korea
- Volunteers
- 110 people
- Sponsor
- Pfizer
Alpha1-Antitrypsin Deficiency
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency
The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC…
- Trial name
- NCT04722887
- Testing
- Alpha-1 15%, Liquid Alpha1-Proteinase Inhibitor (Human)
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Grifols Therapeutics LLC
Duodenal Ulcer
Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection
The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with duodenal ulcer.
- Trial name
- NCT03050359
- Testing
- TAK-438, Lansoprazole, Bismuth-Containing Quadruple Therapy
- Where
- 81 sites in China, Philippines and 2 more
- Volunteers
- 533 people
- Sponsor
- Takeda
Venous Thrombosis, Deep Vein Thrombosis
Deep Vein Thrombosis Treatment With the Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients Using a Strong CYP 3A4 Inducer
This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who concomitantly use a strong cytochrome P450…
- Trial name
- NCT00786422
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 16 sites in Australia, Austria and 7 more
- Volunteers
- 25 people
- Sponsor
- Bayer