Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)

NCT ID: NCT01277822

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-30
• Study Completion Date: 2013-04-22

Brief Summary

This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.

Conditions

Hypertension

Study Design

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

Study Groups

Losartan/amlodipine Treatment Arm

One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.

Group Type: EXPERIMENTAL

Losartan (+) amlodipine

Intervention Type: DRUG

One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.

Placebo to match amlodipine

Intervention Type: DRUG

2 tablets containing placebo, orally, once daily, for 8 weeks.

Amlodipine Treatment Arm

2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Placebo to match losartan/amlodipine tablets

Intervention Type: DRUG

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

Amlodipine camsylate

Intervention Type: DRUG

2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.

Interventions

Losartan (+) amlodipine

One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.

Intervention Type: DRUG

Placebo to match losartan/amlodipine tablets

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

Intervention Type: DRUG

Amlodipine camsylate

2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.

Intervention Type: DRUG

Placebo to match amlodipine

2 tablets containing placebo, orally, once daily, for 8 weeks.

Intervention Type: DRUG

Other Intervention Names

COZAAR XQ™

Eligibility Criteria

Inclusion Criteria

• Participants with essential hypertension:

• who are on single drug therapy
• who are newly diagnosed and not yet taking any drug therapy, or have not had any drug therapy for at least 2 weeks prior to entering study
• who have blood pressure readings of 90mmHg ≤ MSDBP < 110mmHg and 140mmHg ≤ MSSBP <180mmHg after 2 weeks wash-out for patients on single agent.
• Randomization (Visit 3)

• After dosing of amlodipine 5mg for 6 weeks, blood pressure readings are:

• 90mmHg ≤ MSDBP < 110mmHg and 140mmHg ≤ MSSBP < 180mmHg.

Exclusion Criteria

• Participant with MSDBP ≥ 110mmHg or MSSBP ≥ 180mmHg.
• Participant currently taking ≥ 2 antihypertensive medications (note: fixed-dose combination medicine should be counted as the number of active ingredients).
• Participant with known secondary hypertension of any etiology.
• Participant with malignant hypertension or current evidence of impending or active malignant hypertension, including headache, papilledema, cardiac ischemia, or pulmonary congestion precipitated by elevated blood pressure.
• Participant with known intolerance, contraindication or hypersensitivity to any component of dihydropyridines, angiotensin II receptor blockers.
• Participant showing positive in pregnancy test, lactating woman, or woman who intends to get pregnant during the study period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

0954F-399

Identifier Type: -

Identifier Source: org_study_id