Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Amlodipine; Losartan

Criteria

Inclusion Criteria:

• 18 aged or over

• Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs

• Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg

Exclusion Criteria:

• Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days

• ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening

• History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics

• Secondary hypertension or suspected to be

• Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months

• Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus

• History of severe neurovascular disease, severe heart disease

• Known as moderate or malignant retinopathy.

• Renal diseases; serum creatinine ≥ 2mg/dl

• Hepatic diseases; increase in ALT or AST ≥ 2xUNL

• Anuria

• Hyponatremia/hypokalemia or hypercalcemia

• Active Gout

• Surgical or medical diseases which might significantly change ADME of medicines

• History of malignant tumor

• Autoimmune diseases

• History of alcohol or drug abuse

• Positive to pregnancy test, nursing mother, woman with an intention of pregnancy

• Considered inappropriate to participate in the clinical trial with any reason, based on investigator's decision

Other protocol-defined inclusion/exclusion criteria may apply