Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart...
Date First Received: August 24, 2007
Last Updated: April 13, 2009
Verified by: Corthera, Inc., April 2009
Clinical Trial Phase: Phase 2/Phase 3 | Start Date: October 2007
Overall Status: Recruiting
Brief Summary
Official Title: “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”
Condition Keyword(s):
Intervention(s):
Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Relaxin
- intravenous infusion for 48 h
Outcome Measures for this Clinical Trial
Primary Measures
- Signs and symptoms of acute heart failure
Secondary Measures
- Renal function
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Corthera, Inc.
Overall Clinical Trial Officials and Contacts
Sam Teichman, MD Study Director Corthera, Inc.
Overall Contact: Sam Teichman, MD 925.314.0569
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00520806
Study ID Number: RLX.CHF.003
ClinicalTrials.gov Identifier: NCT00520806
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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