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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Placebo to L50/H12.5/A5; Drug: Placebo to L50/H12.5; Drug: L50/H12.5; Drug: L50/H12.5/A5

Study type: Interventional

Funder types: Industry

Identifiers

NCT01299376

0954E-356

Details and patient eligibility

About

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.

Enrollment: 286 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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286 participants in 2 patient groups

L50/H12.5/A5→L50/H12.5/A5

Experimental group

Description:

One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open label extension.

Treatment:

Drug: L50/H12.5/A5

Drug: Placebo to L50/H12.5

L50/H12.5→L50/H12.5/A5

Active Comparator group

Description:

One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension

Treatment:

Drug: L50/H12.5

Drug: Placebo to L50/H12.5/A5