A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)

• Status: Completed
• Trial end date: 2012-12-04
• Target enrollment: 0
• Participant gender: All

Summary

This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: 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 >=90mmHg and < 110mmHg.

• Participant has a mean trough SiSBP of >=140mmHg and < 200mmHg.

• 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 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.

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