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

Hanmi Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: Amlodipine plus Losartan

Drug: Amlodipine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00940667

HM-ALOS-301

Details and patient eligibility

About

The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and amlodipine alone in patients with essential hypertension inadequately controlled on amlodipine monotherapy.

Enrollment

185 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients over 18 years of age
Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP ≥ 90 mmHg for drug-treated patient, sit DBP ≥ 95 mmHg for drug-naïve patient)
Non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit DBP ≥ 90mmHg)

Exclusion criteria

mean sit SBP ≥ 200 mmHg or mean sit DBP ≥ 120 mmHg at screening
mean sit SBP ≥ 180 mmHg or mean sit DBP ≥ 120 mmHg after 4 weeks of amlodipine 5 mg treatment
has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
Secondary hypertensive patient or suspected to be
Uncontrolled diabetes mellitus patients
Severe heart disease or severe neurovascular disease
Known as severe or malignant retinopathy
Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
History of malignancy tumor
History of autoimmune disease
History of alcohol or drug abuse
Positive to pregnancy test, nursing mother, has an intention on pregnancy
Considered by investigator as not appropriate to participate in the clinical study with othe reason