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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E); Drug: Amlodipine besylate; Drug: Placebo to losartan potassium; Drug: Placebo to amlodipine besylate; Drug: Placebo to MK-0954E; Drug: Losartan potassium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01302691

0954E-357

Details and patient eligibility

About

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).

Enrollment: 327 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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327 participants in 2 patient groups

L50/H12.5/A5

Experimental group

Description:

Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.

Treatment:

Drug: Placebo to losartan potassium

Drug: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)

Drug: Placebo to amlodipine besylate

L50 + A5

Active Comparator group

Description:

Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.

Treatment:

Drug: Amlodipine besylate

Drug: Losartan potassium

Drug: Placebo to MK-0954E