drugset / Trial / NCT01277822

Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)

NCT01277822 ↗

Phase 4 Completed 334 enrolled Organon and Co
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.

Timeline

Start
2011-05-30
Primary completion
2013-04-22
Completion
2013-04-22

Outcome

Missed primary endpoint

registry analysis (unspecified test); Losartan/Amlodipine vs Amlodipine; p = 0.1339; Mean Difference (Final Values) -1.3 (95% CI -3.0 to 0.4); t-test, 2 sided NCT01277822 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amlodipine Other / unclassified 5 mg Oral
Comparator Amlodipine Other / unclassified 10 mg Oral
Subject Losartan Other / unclassified 100 mg Oral

Indications