MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)

• Status: Completed
• Trial end date: 2012-09-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Amlodipine; Hydrochlorothiazide; Losartan

Criteria

Inclusion criteria:

• Participant has a diagnosis of essential hypertension

• Participant is being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication

• Participant has a mean trough SiDBP of ≥ 90 mmHg and < 110 mmHg

• Participant has a mean trough SiSBP of ≥ 140 mmHg and < 200 mmHg

• Participant has no clinically significant abnormality at screening visit

Exclusion criteria:

• Participant is currently taking >2 antihypertensive medications

• Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-Lotan or Preminent, amlodipine or dihydropyridine drug and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines)

• Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence

• Participant is pregnant or breastfeeding, or expecting to conceive OR the pregnancy test is positive at screening visit (Visit 1)

• Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent