NCT01277822

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

The 8 Weeks, Multicenter, Randomized, Double-blind, Clinical Study To Evaluate Efficacy Of Treatment With Losartan/Amlodipine 100/5 mg Combination Compared To Amlodipine 10 mg Monotherapy In Hypertensive Patients Who Are Not Appropriately Respond To Amlodipine 5 mg Monotherapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Losartan (+) amlodipine	One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.
DRUG	Placebo to match losartan/amlodipine tablets	One tablet containing placebo, orally, once daily, for 8 weeks.
DRUG	Amlodipine camsylate	2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.
DRUG	Placebo to match amlodipine	2 tablets containing placebo, orally, once daily, for 8 weeks.

Timeline

• Start date: 2011-05-30
• Primary completion: 2013-04-22
• Completion: 2013-04-22
• First posted: 2011-01-17
• Last updated: 2024-06-20
• Results posted: 2014-04-24