Clinical trials: Physiological Effects of Drugs
ER-Positive HER2-Negative Breast Cancer
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in…
- Trial name
- SERENA-6 (NCT04964934)
- Testing
- AZD9833, Anastrozole, Letrozole
- Where
- 264 sites in United States, Australia and 21 more
- Volunteers
- 315 people
- Sponsor
- AstraZeneca
Type 2 Diabetes
Study to Evaluate the Safety and Efficacy of the Addition of Omarigliptin (MK-3102) Compared With the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-026)
This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy.
- Trial name
- NCT01841697
- Testing
- Omarigliptin, Sitagliptin, Open-label Metformin
- Volunteers
- 642 people
- Sponsor
- Merck Sharp & Dohme LLC
ER-Positive HER2-Negative Breast Cancer
A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone…
- Trial name
- SERENA-4 (NCT04711252)
- Testing
- AZD9833, Anastrozole, Palbociclib
- Where
- 263 sites in United States, Austria and 25 more
- Volunteers
- 1,371 people
- Sponsor
- AstraZeneca
Physiological Effects of Drugs, Neoplasms by Histologic Type
Safety, Tolerability and Pharmacokinetics/Pharmacodynamics (PK/PD) of SHR-1603 in Subjects With Advanced Malignancies
SHR-1603-I-101 is an single-arm, open-label, dose finding phase I clinical trial of SHR-1603 in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases.
- Conditions
- Physiological Effects of Drugs, Neoplasms by Histologic Type, Lymphoma, Hematologic Neoplasms
- Trial name
- NCT03722186
- Testing
- SHR-1603
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Immunoglobulin A Nephropathy, Glomerular Disease
Safety and Efficacy Study of VIS649 for IgA Nephropathy
The purpose of this study is to evaluate the efficacy and safety of VIS649 in participants with immunoglobulin A (IgA) Nephropathy (IgAN)
- Conditions
- Immunoglobulin A Nephropathy, Glomerular Disease, IgAN
- Trial name
- NCT04287985
- Testing
- Low Dose-VIS649, Medium Dose-VIS649, High Dose-VIS649
- Where
- 93 sites in United States, Australia and 13 more
- Volunteers
- 155 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Proctitis, Proctosigmoiditis
The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).
- Trial name
- NCT01349673
- Testing
- Budesonide Foam
- Where
- United States
- Volunteers
- 114 people
- Sponsor
- Bausch Health Americas, Inc.
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
Obesity, Overweight
A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)
The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction in participants who previously completed treatment with injectable tirzepatide (Zepbound) or injectable…
- Trial name
- NCT06584916
- Testing
- Orforglipron
- Where
- 29 sites in United States, Puerto Rico
- Volunteers
- 376 people
- Sponsor
- Eli Lilly and Company
Neuromuscular Agents, Peripheral Nervous System Agents
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
The purpose of this study is to assess the safety and efficacy of NT 201 compared with placebo in participants with moderate to severe platysma prominence.
- Conditions
- Neuromuscular Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Acetylcholine Release Inhibitors
- Trial name
- PLATINUM EU (NCT07210463)
- Testing
- NT 201
- Where
- 26 sites in France, Germany and 2 more
- Volunteers
- 300 people
- Sponsor
- Merz Aesthetics GmbH
Non-small-cell Lung Cancer (NSCLC) Stage IV
A Phase III Trial of Recombinant Human Apo-2 Ligand for Injection
The trial is to evaluate the efficacy and safety of recombinant human Apo-2 ligand in treating patients with advanced retreated non-small cell lung cancer
- Trial name
- NCT03083743
- Testing
- Recombinant human Apo-2 ligand for Injection
- Where
- China
- Volunteers
- 417 people
- Sponsor
- Shanghai Gebaide Biotechnology Co., Ltd.
Peripheral Artery Disease (PAD)
Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR
To compare the effect of ticagrelor versus aspirin on the change in peak walking time, evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in patients with peripheral artery disease who have…
- Trial name
- TI-PAD EVR (NCT02227368)
- Testing
- Ticagrelor, Comparator
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Acute Pain
A Phase 2 Study to Evaluate Analgesic Effect of IV CR845 For Pain Following Bunionectomy Surgery
This is a single-center, randomized, double blind, placebo controlled, parallel group proof of concept study to evaluate the analgesic efficacy as well as the safety, tolerability and pharmacokinetic profile of CR845 in patients…
- Trial name
- NCT01789476
- Testing
- CR845
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Cara Therapeutics, Inc.
Neuromuscular Agents, Peripheral Nervous System Agents
A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States
The purpose of this study is to assess the safety and efficacy of NT 201 compared with placebo in participants with moderate to severe platysma prominence.
- Conditions
- Neuromuscular Agents, Peripheral Nervous System Agents, Physiological Effects of Drugs, Acetylcholine Release Inhibitors
- Trial name
- PLATINUM US (NCT07122193)
- Testing
- NT 201
- Where
- 28 sites in United States, Puerto Rico
- Volunteers
- 300 people
- Sponsor
- Merz North America, Inc.
AMD, nAMD
Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD).
- Conditions
- AMD, nAMD, Wet Age-related Macular Degeneration, wAMD
- Trial name
- ATMOSPHERE (NCT04704921)
- Testing
- ABBV-RGX-314, Ranibizumab (LUCENTIS®)
- Where
- 89 sites in United States
- Volunteers
- 671 people
- Sponsor
- AbbVie
Hypogonadism
Oral Testosterone for the Treatment of Hypogonadism
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors.
- Trial name
- NCT01717768
- Testing
- TSX-002
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- TesoRx Pharma, LLC
Candidemia, Mycoses
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.
- Conditions
- Candidemia, Mycoses, Fungal Infection, Fungemia
- Trial name
- ReSPECT (NCT04368559)
- Testing
- Rezafungin for Injection, Posaconazole, Fluconazole
- Where
- 53 sites in United States, Belgium and 7 more
- Volunteers
- 602 people
- Sponsor
- Mundipharma Research Limited
Breast Neoplasms, Peritoneal Neoplasms
Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy
Monoclonal antibodies can transport and deliver radioactive elements capable of releasing sufficient amounts of energy to destroy tumor cells.
- Conditions
- Breast Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms
- Trial name
- NCT01384253
- Testing
- ²¹²Pb-TCMC-Trastuzumab, trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Orano Med LLC
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
Parkinson Disease, Movement Disorders
Long-Term Follow-up Safety After DDS Implantation With/Without CDNF Infusions
This study is a follow up to the HP-CD-CL-2002 clinical study. It evaluates the long-term safety in patients with Parkinson's disease after implantation of an investigational drug delivery system (DDS) with or without infusions…
- Conditions
- Parkinson Disease, Movement Disorders, Neuro-Degenerative Disease, Nervous System Diseases
- Trial name
- NCT04228653
- Testing
- Renishaw Drug Delivery System
- Where
- 3 sites in Finland, Sweden
- Volunteers
- 15 people
- Sponsor
- Renishaw