NCT01858480

Study To Evaluate D-Ribose For The Treatment of Congestive Heart Failure

Randomized, Double-Blind, Placebo-Controlled Study To Evaluate D-Ribose For The Treatment Of Congestive Heart Failure

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: RiboCor, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and to determine the efficacy of D-ribose for the treatment of congestive heart failure (CHF) in subjects who have been stabilized following hospitalization with acute decompensation.

Detailed description

This is a phase IIa, randomized, double-blind, placebo-controlled, multi-center study of D-ribose administered via peripheral intravenous line for 24 hours to stabilized hospitalized patients following standard of care treatment for acute decompensation of CHF, followed by oral dosing of D-ribose three times a daily through the remainder of the inpatient hospital stay and outpatient period of 3 months. Subjects will complete Pretreatment Screening procedures only after the Investigator has established that they have met the pre-specified criteria for stabilization of heart failure, and be randomized to treatment no more than 7 days after admission to the hospital.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DRUG	D-ribose	D-ribose powder for oral solution and D-ribose for injection.
OTHER	Placebo	Placebo dosage form designed to mock active.

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-05-21
• Last updated: 2016-07-14

Locations

24 sites across 2 countries: United States, Canada