Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension

Hanmi Pharmaceutical

Status and phase

Completed

Phase 2

Conditions

Hypertension

Treatments

Drug: Amlodipine plus Losartan

Drug: Amlodipine

Drug: Losartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00942344

HM-ALOS-201

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.

Enrollment

320 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged between 18 and 75
Patients with essential hypertension {95 mmHg ≤ sitDBP< 115 mmHg at the end of placebo run-in treatment period}

Exclusion criteria

Patients with mean sitSBP ≥ 200 mmHg
Patients with known hypersensitivity to Dihydropyridine or angiotensin II receptor blockers
Patients with secondary hypertension or suspected secondary hypertension
Patients with malignant hypertension
Patients who have received any medications with possible interactions with study drugs
Patients with uncontrolled diabetes
Patients with severe heart disease or severe cerebrovascular disease
Patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
Patients with a history of malignant disease
Patients with a history of autoimmune disease
Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
Patients inappropriate to be included in study population due to other reasons at the discretion of the investigator