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

NCT ID: NCT01302691

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 327 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2012-04-01

Brief 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).

Conditions

Hypertension

Study Design

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

Study Groups

L50/H12.5/A5

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks.

Placebo to losartan potassium

Intervention Type: DRUG

One tablet, containing placebo, orally, once daily, for 8 weeks.

Placebo to amlodipine besylate

Intervention Type: DRUG

One capsule, containing placebo, orally, once daily, for 8 weeks.

L50 + A5

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

Group Type: ACTIVE_COMPARATOR

Losartan potassium

Intervention Type: DRUG

One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks.

Amlodipine besylate

Intervention Type: DRUG

One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks.

Placebo to MK-0954E

Intervention Type: DRUG

One tablet, containing placebo, orally, once daily, for 8 weeks.

Interventions

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

One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks.

Intervention Type: DRUG

Losartan potassium

One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks.

Intervention Type: DRUG

Amlodipine besylate

One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks.

Intervention Type: DRUG

Placebo to MK-0954E

One tablet, containing placebo, orally, once daily, for 8 weeks.

Intervention Type: DRUG

Placebo to losartan potassium

One tablet, containing placebo, orally, once daily, for 8 weeks.

Intervention Type: DRUG

Placebo to amlodipine besylate

One capsule, containing placebo, orally, once daily, for 8 weeks.

Intervention Type: DRUG

Eligibility 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.

• 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)

Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Shirakawa M, Azuma K, Fujita KP. Add-on effect of hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension uncontrolled with losartan 50 mg and amlodipine 5 mg. Hypertens Res. 2015 May;38(5):329-35. doi: 10.1038/hr.2015.3. Epub 2015 Feb 26.

Reference Type: RESULT

PMID: 25716649 (View on PubMed)

Other Identifiers

0954E-357

Identifier Type: -

Identifier Source: org_study_id