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Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets | Clinical Trials | Clareo Health

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Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets

Randomized, Open-Label, Daily Dose, 2-sequence, 2-way Crossover Pharmacodynamic and Pharmacokinetic Study of BiDil XR Capsules and Commercial BiDil Tablets in Self-identified Black Patients, Who Are Slow Acetylators, With Heart Failure

NCT02522208•Arbor Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

A multiple-center, open-label, randomized, daily dose, two-sequence, two-way crossover pharmacodynamics (PD) and pharmacokinetic (PK) study of BiDil XR capsules and commercial BiDil tablets in Self-identified Black Patients, who are Slow Acetylators, with Heart Failure and have not received BiDil, isosorbide dinitrate (ISDN), or hydralazine hydrochloride (HCl) for at least 30 days prior to screening. The study consists of two doses of BiDil XR capsules (dosed at 0 hr and 9 hr) and three doses of BiDil tablets (dosed at 0 hr, 6 hr and 12 hr).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Self-identified Black, stable, chronic heart failure male or female subjects classified as having New York Heart Association (NYHA) Class II or III, diagnosed at least 3 months prior to Screening.
•Clinically stable outpatient, receiving standard, stable treatment regimen for heart failure (HF), at least 2 weeks prior to screening and throughout the duration of the trial. Subjects receiving beta-blockers must have been taking these for at least 3 months.
•All other medications must have been at a stable dose for at least 2 weeks prior to first dose
•Subjects must not have received BiDil, isosorbide dinitrate or hydralazine HCl for at least 30 days prior to Screening
•Have an adequate and demonstrable baseline Tricuspid regurgitation jet, visible inferior vena cava, and adequate right heart echocardiogram (with or without saline bubble contrast) allowing measurements to be made.
•Baseline PA systolic pressures \> 35 mmHg
•Slow acetylator
•Adult subjects at least 18 years old or state-specific age of majority.
•Clinical lab tests negative for HIV, Hepatitis B surface antigen and Hepatitis C antibody.
•Urine testing negative for alcohol and drugs of abuse.
+9 more criteria

Exclusion Criteria

•Have significant valvular heart disease, hemodynamically significant obstructive hypertrophic cardiomyopathy, active myocarditis, or uncontrolled hypertension.
•Presence of severe, clinical right heart failure.
•Symptoms of unstable angina, a myocardial infarction, cardiac surgery, or percutaneous coronary intervention within 1 month prior to Screening
•Have coronary artery disease likely to require coronary artery bypass grafting or percutaneous coronary intervention during the ensuing 3 months.
•Had cardiac arrest or a sustained ventricular tachycardia considered life threatening and requiring intervention within 3 months, unless treated with implantable cardioverter-defibrillator.
•other causes of pulmonary hypertension that may confound pharmacodynamic assessments of heart failure
•Active malignancy or any non-cardiac life-limiting disease.
•Have significant hepatic, renal, or other disease that might confound the study results or present a risk to the subject.
•Had a stroke within the past 3 months.
•Received parenteral inotropic therapy within 1 month.
+13 more criteria

Locations (5)

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Linfritz Research Institue Inc

Coral Gables, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Morehouse School of Medicine

Atlanta, Georgia, United States

Center for Medical Research, LLC

Providence, Rhode Island, United States

Key Dates

Start Date

September 1, 2015

Primary Completion Date

April 1, 2016

Completion Date

April 1, 2016

Last Updated

November 8, 2016

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

BiDil XR

DRUG

BiDil Immediate Release (IR)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacodynamic and Pharmacokinetic Study of BiDil Extended-release Capsules and Commercial BiDil Tablets

Inclusion Criteria

Exclusion Criteria

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