MK-0954E Study in Participants With Hypertension (MK-0954E-357)

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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).

• 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 single or dual 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.