NCT00443690 (REACH UP) is a Phase 3 clinical trial of rolofylline in Heart Failure, Congestive, sponsored by NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

Who is sponsoring NCT00443690?

NCT00443690 is sponsored by NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

What drugs are being tested in NCT00443690?

Interventions in NCT00443690: rolofylline, Comparator: Placebo (unspecified).

What condition does NCT00443690 study?

NCT00443690 studies Heart Failure, Congestive.

Is NCT00443690 still recruiting?

NCT00443690 is currently completed. Last updated 19 February 2009.

Last reviewed 2009-02-19 · How we verify

NCT00443690: REACH UP

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of KW-3902 Injectable Emulsion on Heart Failure Signs and Symptoms, Diuresis, Renal Function, and Clinical Outcomes in Subjects Hospitalized With Worsening Renal Function and Heart Failure Requiring Intravenous Therapy

Completed Phase 3 Last updated 19 February 2009

What this trial tests

Phase 3 trial testing rolofylline in Heart Failure, Congestive in 480 participants. Completed in 1 January 2009.

Timeline

1 August 2007

Primary endpoint
1 January 2009

1 January 2009

Quick facts

Lead sponsor	NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	480
Start date	1 August 2007
Primary completion	1 January 2009
Estimated completion	1 January 2009

Drugs / interventions tested

rolofylline — full drug profile →
Comparator: Placebo (unspecified) — full drug profile →

Conditions studied

Heart Failure, Congestive — all drugs for Heart Failure, Congestive →

Sponsor

NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →

Who can join

18 and older, any sex, with Heart Failure, Congestive. 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.

Effect on heart failure signs and symptoms
Time frame: through day 7
Effect on renal function
Time frame: through Day 7

Sponsor's own description

To evaluate the effect of KW-3902IV, in addition to standard therapy, on the proportion of worsening heart failure and worsening renal function, and on the proportion of deaths or rehospitalizations for heart failure or worsening renal function, and to estimate and compare within-trial medical resource utilization and direct medical costs between subjects treated with KW 3902IV versus placebo.

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, Congestive

Currently open trials in the same condition.

NCT06689215 — Comparison of Noninvasive vs. Invasive Hemodynamic Measurements · active not recruiting
NCT06218199 — Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts · Phase 4 · recruiting

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 NCT00443690 (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 NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Last refreshed: 19 February 2009

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/NCT00443690.

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