Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00090259
First received: August 25, 2004
Last updated: October 21, 2010
Last verified: October 2010
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Purpose
This is a multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Drug: Losartan 50 mg Drug: Losartan 150 mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-center, Double-Blind, Randomized, Parallel Group Study to Evaluate the Effects of Two Different Doses of Losartan on Morbidity and Mortality in Patients With Symptomatic Heart Failure Intolerant of ACE Inhibitor Treatment |
Resource links provided by NLM:
Drug Information available for:
Potassium bicarbonate
Potassium chloride
Losartan
Losartan potassium
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure [ Time Frame: Entire follow-up (median = 4.7 years) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization [ Time Frame: Entire follow-up (median = 4.7 years) ] [ Designated as safety issue: No ]Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure.
- Number of Participants That Died (Any Cause) [ Time Frame: Entire follow-up (median = 4.7 years) ] [ Designated as safety issue: No ]
- Number of Participants That Were Hospitalized for Heart Failure [ Time Frame: Entire follow-up (median = 4.7 years) ] [ Designated as safety issue: No ]
- Number of Participants That Experienced Cardiovascular Hospitalization [ Time Frame: Entire follow-up (median = 4.7 years) ] [ Designated as safety issue: No ]
| Enrollment: | 3834 |
| Study Start Date: | October 2001 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Losartan 50 mg
50-mg losartan tablet administered daily with 1 tablet of 100-mg losartan placebo beginning Week 1 and continuing to end of study (up to 4 years)
|
Drug: Losartan 50 mg
50-mg losartan oral tablet
Other Name: Losartan potassium
|
|
Experimental: Losartan 150 mg
Titrated losartan administration up to daily 150-mg losartan: Week 1, daily 50-mg losartan tablet coadministered with 100-mg losartan placebo; Week 2, daily 50-mg losartan placebo coadministered with 100-mg losartan; Week 3 to end of study (up to 4 years), daily 50-mg losartan tablet coadministered with 100-mg losartan
|
Drug: Losartan 150 mg
100-mg losartan oral tablet + 50-mg losartan oral tablet
Other Name: Losartan potassium
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Symptomatic heart failure with known or recently diagnosed intolerance of treatment with first-line medication for heart failure
- May or may not be receiving an alternative and/or additional drug treatment
Contacts and Locations More Information
Additional Information:
No publications provided by Merck
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00090259 History of Changes |
| Other Study ID Numbers: | 2004_004, MK0954-948 |
| Study First Received: | August 25, 2004 |
| Results First Received: | June 30, 2010 |
| Last Updated: | October 21, 2010 |
| Health Authority: | Peru: General Directorate of Pharmaceuticals, Devices, and Drugs |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Losartan Anti-Arrhythmia Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013