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

NCT ID: NCT01299376

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-24
• Study Completion Date: 2012-09-20

Brief 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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

L50/H12.5/A5→L50/H12.5/A5

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.

Group Type: EXPERIMENTAL

L50/H12.5/A5

Intervention Type: DRUG

Placebo to L50/H12.5

Intervention Type: DRUG

L50/H12.5→L50/H12.5/A5

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

Group Type: ACTIVE_COMPARATOR

L50/H12.5

Intervention Type: DRUG

Placebo to L50/H12.5/A5

Intervention Type: DRUG

Interventions

L50/H12.5/A5

Intervention Type: DRUG

L50/H12.5

Intervention Type: DRUG

Placebo to L50/H12.5/A5

Intervention Type: DRUG

Placebo to L50/H12.5

Intervention Type: DRUG

Other Intervention Names

MK-0954E; MK-0954H

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Shirakawa M, Azuma K, Fujita KP. Efficacy and safety of fixed-dose losartan/hydrochlorothiazide/amlodipine combination versus losartan/hydrochlorothiazide combination in Japanese patients with essential hypertension. Clin Exp Hypertens. 2015;37(3):260-6. doi: 10.3109/10641963.2014.954712. Epub 2014 Oct 1.

Reference Type: RESULT

PMID: 25271811 (View on PubMed)

Other Identifiers

0954E-356

Identifier Type: -

Identifier Source: org_study_id