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 MK-954H (L50/H12.5 mg) [PREMINENT®] and an Open-label, Long-term Clinical Trial to Study the Safety of MK-0954E
In Brief
A Phase 3 clinical trial evaluating L50/H12.5/A5, L50/H12.5, and 2 other interventions for Hypertension. Completed, enrolled 286 participants.
Detailed Summary
This study has two parts. In the first part, the efficacy and safety MK-0954E (losartan potassium 50 mg \[L50\] (+) hydrochlorothiazide 12.5 mg \[H12.5\] (+) amlodipine besylate 5mg \[A5\]) will be evaluated and compared to the efficacy and safety of MK-0954H (L50/H12.5) in Japanese participants. In the second part, the safety and tolerability of long-term use of open-label MK-0954E in participants with hypertension will be evaluated. The primary hypothesis is that MK-0954E is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to MK-954H (L50/H12.5 mg) in Japanese participants with essential hypertension who are not adequately controlled following a 8-week treatment with filter period study drug of MK-954H.