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

• Status: Completed
• Trial end date: 2013-04-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Amlodipine; Losartan

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.