MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)
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.
Timeline
- Start
- 2011-01-24
- Primary completion
- 2011-11-16
- Completion
- 2012-09-20
Outcome
Met primary endpoint
registry analysis (superiority or other test); L50/H12.5/A5 vs L50/H12.5; p <0.001; Difference in Least-squares Means -5.9 (95% CI -7.5 to -4.2); Contrained Longitudinal Data Analysis NCT01299376 ↗
paper After 8 weeks, diastolic and systolic BP were reduced significantly more with L50/H12.5/A5 versus L50/H12.5 (both p < 0.001). PMID 25271811 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 5 mg | Oral |
| Background | Hydrochlorothiazide | Unknown | 12.5 mg | Oral |
| Background | Losartan | Other / unclassified | 50 mg | Oral |