Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure - Tabular View

Tracking Information

First Received Date ^ICMJE

August 24, 2007

Last Updated Date

April 13, 2009

Start Date ^ICMJE

October 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Signs and symptoms of acute heart failure

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00520806 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Renal function

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure

Official Title ^ICMJE

A Phase II/III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure

Brief Summary

Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure

Detailed Description

This is an international, randomized, double-blind, placebo-controlled trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure. A pilot study will determine the optimum dose of relaxin which will be studied further in the main portion of the trial.

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Heart Failure, Congestive

Intervention ^ICMJE

Drug: Relaxin

Study Arms / Comparison Groups

Publications *

Teerlink JR, Metra M, Felker GM, Ponikowski P, Voors AA, Weatherley BD, Marmor A, Katz A, Grzybowski J, Unemori E, Teichman SL, Cotter G. Relaxin for the treatment of patients with acute heart failure (Pre-RELAX-AHF): a multicentre, randomised, placebo-controlled, parallel-group, dose-finding phase IIb study. Lancet. 2009 Apr 25;373(9673):1429-39. Epub 2009 Mar 28.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Hospitalized for acute heart failure
Dyspnea at rest or with minimal exertion
Pulmonary congestion
Able to provide informed consent

Exclusion Criteria:

Use of other IV therapies for acute heart failure
Fever or sepsis
Recent major neurologic event
Recent major surgery
Recent acute coronary syndrome
Other recent investigational drug use

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sam Teichman, MD

925.314.0569

Location Countries ^ICMJE

United States, Israel

Administrative Information

NCT ID ^ICMJE

NCT00520806

Responsible Party

Sam Teichman, Chief Medical Officer, Corthera, Inc.

Study ID Numbers ^ICMJE

RLX.CHF.003

Study Sponsor ^ICMJE

Corthera, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Sam Teichman, MD

Corthera, Inc.

Information Provided By

Corthera, Inc.

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP