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

Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948)

Sponsors

Lead sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
Brief Summary

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.

Overall Status Completed
Start Date December 19, 2001
Completion Date May 13, 2009
Primary Completion Date March 31, 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure Entire follow-up (median = 4.7 years)
Secondary Outcome
Measure Time Frame
Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization Entire follow-up (median = 4.7 years)
Number of Participants That Died (Any Cause) Entire follow-up (median = 4.7 years)
Number of Participants That Were Hospitalized for Heart Failure Entire follow-up (median = 4.7 years)
Number of Participants That Experienced Cardiovascular Hospitalization Entire follow-up (median = 4.7 years)
Enrollment 3834
Condition
Intervention

Intervention type: Drug

Intervention name: Losartan 50 mg

Description: 50-mg losartan oral tablet

Arm group label: Losartan 50 mg

Other name: Losartan potassium

Intervention type: Drug

Intervention name: Losartan 150 mg

Description: 100-mg losartan oral tablet + 50-mg losartan oral tablet

Arm group label: Losartan 150 mg

Other name: Losartan potassium

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Medical Monitor Study Director Merck Sharp & Dohme Corp.
Verification Date

March 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Losartan 50 mg

Arm group type: Experimental

Description: 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)

Arm group label: Losartan 150 mg

Arm group type: Experimental

Description: 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

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov