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

Organon

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Drug: Losartan 50 mg; Drug: Losartan 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090259

2004_004

0954-948

Details and patient eligibility

About

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.

Enrollment: 3,834 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,834 participants in 2 patient groups

Losartan 50 mg

Experimental group

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)

Treatment:

Drug: Losartan 50 mg

Losartan 150 mg

Experimental group

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

Treatment:

Drug: Losartan 150 mg