At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Active-Comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954E in Japanese Patients With Essential Hypertension Uncontrolled With Losartan and Amlodipine Co-administration
In Brief
A Phase 3 clinical trial evaluating losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E), Losartan potassium, and 4 other interventions for Hypertension. Completed, enrolled 327 participants.
Detailed Summary
This study is being done to evaluate the efficacy, safety, and tolerability of losartan potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5) + amlodipine besylate 5 mg (A5) (MK-0954E). The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to L50+A5 in Japanese participants with essential hypertension who are not adequately controlled following an 8-week treatment with filter period study drug (L50+A5).
Study Details
Timeline
Interventions
One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks.
One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
One tablet, containing placebo, orally, once daily, for 8 weeks.
One tablet, containing placebo, orally, once daily, for 8 weeks.
One capsule, containing placebo, orally, once daily, for 8 weeks.