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

Organon

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Placebo to match amlodipine; Drug: Losartan (+) amlodipine; Drug: Amlodipine camsylate; Drug: Placebo to match losartan/amlodipine tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT01277822

0954F-399

Details and patient eligibility

About

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

Enrollment: 334 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

334 participants in 2 patient groups

Losartan/amlodipine Treatment Arm

Experimental group

Description:

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.

Treatment:

Drug: Losartan (+) amlodipine

Drug: Placebo to match amlodipine

Amlodipine Treatment Arm

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo to match losartan/amlodipine tablets

Drug: Amlodipine camsylate