NCT02522208 is a Phase 1 clinical trial of BiDil XR in Heart Failure, sponsored by Arbor Pharmaceuticals, Inc..

Who is sponsoring NCT02522208?

NCT02522208 is sponsored by Arbor Pharmaceuticals, Inc..

What drugs are being tested in NCT02522208?

Interventions in NCT02522208: BiDil XR, BiDil Immediate Release (IR).

What condition does NCT02522208 study?

NCT02522208 studies Heart Failure.

Is NCT02522208 still recruiting?

NCT02522208 is currently completed. Last updated 7 November 2016.

Last reviewed 2016-11-07 · How we verify

NCT02522208

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 7 November 2016

What this trial tests

Phase 1 trial testing BiDil XR in Heart Failure in 12 participants. Completed in 1 April 2016.

Timeline

1 September 2015

Primary endpoint
1 April 2016

1 April 2016

Quick facts

Lead sponsor	Arbor Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 September 2015
Primary completion	1 April 2016
Estimated completion	1 April 2016
Sites	5 locations across United States

Drugs / interventions tested

BiDil XR — full drug profile →
BiDil Immediate Release (IR) — full drug profile →

Conditions studied

Heart Failure — all drugs for Heart Failure →

Sponsor

Arbor Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Pulmonary Artery (PA) Systolic Pressure change from baseline to each post dose timepoint for 28 hours
Time frame: 6 days
assess the treatment effect of BiDil and BiDil XR on Pulmonary Artery Systolic Pressure (PASP) by Doppler echocardiography

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Heart Failure

Currently open trials in the same condition.

NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting

Other Arbor Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT06247488 — Abuse Potential of HORIZANT With and Without Oxycodone in Healthy, Nondependent Recreational Opioid Users · Phase 4 · completed
NCT06097676 — An Abuse Potential Study of Orally Administered HORIZANT in Healthy, Non-dependent, Recreational Drug Users · Phase 4 · completed
NCT03659929 — Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate · Phase 3 · completed
NCT02684838 — Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry · completed
NCT02235909 — An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02522208 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Arbor Pharmaceuticals, Inc.
Last refreshed: 7 November 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02522208.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing