Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets
NCT02522208 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2016-11-08
Summary
This study will investigate cardiovascular parameters using echocardiographic and pharmacokinetics during a daily dose of BiDil and BiDil Extended Release (XR) compared to a study drug free day.
Conditions
Interventions
- DRUG
-
BiDil XR
fixed combination capsule
- DRUG
-
BiDil Immediate Release (IR)
fixed combination tablet
Sponsors & Collaborators
-
Arbor Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Steve D Caras, MD, PhD · Arbor Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2016-04-30
- Completion
- 2016-04-30
Countries
- United States
Study Locations
More Related Trials
-
v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491
NCT03447990 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure
NCT00082589 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%
NCT04986202 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection Fraction
NCT05139615 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Hemodynamic Effects and Pharmacokinetics of CXL-1020 in Patients With Stable Heart Failure
NCT01092325 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
NCT06017609 ·Status: COMPLETED ·Phase: PHASE2
-
A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
NCT00232180 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure
NCT00454818 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy
NCT05953831 ·Status: WITHDRAWN ·Phase: PHASE2
-
Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure
NCT00259038 ·Status: COMPLETED ·Phase: PHASE2
-
The Effect of Eplerenone and Atorvastatin on Markers of Collagen Turnover in Diastolic Heart Failure
NCT00505336 ·Status: COMPLETED ·Phase: NA
-
Effect of Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing
NCT01868880 ·Status: WITHDRAWN ·Phase: PHASE4
-
Early Use of Ivabradine in Heart Failure
NCT03701880 ·Status: UNKNOWN ·Phase: NA
-
Pharmacokinetics of Oral CK-1827452 in Patients With Stable Heart Failure
NCT00941681 ·Status: COMPLETED ·Phase: PHASE2
-
If Channel Blockade With Ivabradine in Patients With Diastolic Heart Failure
NCT00757055 ·Status: WITHDRAWN ·Phase: PHASE2
-
Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)
NCT00729222 ·Status: COMPLETED ·Phase: PHASE2
-
Stratified Treatment to Ameliorate Diastolic Left Ventricular Stiffness in Heart Failure With Preserved Ejection Fraction
NCT04475042 ·Status: UNKNOWN ·Phase: PHASE2
-
Mechanistic Studies of Nicotinamide Riboside in Human Heart Failure
NCT04528004 ·Status: ACTIVE_NOT_RECRUITING ·Phase: EARLY_PHASE1
-
Real-world Research : Assessment of Effect of Combination of Drugs in the Treatment of Heart Failure
NCT06158711 ·Status: NOT_YET_RECRUITING
-
Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease
NCT04595370 ·Status: COMPLETED ·Phase: PHASE2
-
Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart Failure
NCT02653482 ·Status: COMPLETED ·Phase: PHASE4
-
The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure
NCT00043836 ·Status: COMPLETED ·Phase: PHASE2
-
COlchicine for the Prevention of Post Electrical Cardioversion Recurrence of AF
NCT02582190 ·Status: WITHDRAWN ·Phase: PHASE3
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 5-1058
NCT03708146 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction
NCT03098979 ·Status: COMPLETED ·Phase: PHASE2