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

Hanmi Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: Amlodipine plus Losartan

Drug: Losartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00940680

HM-ALOS-302

Details and patient eligibility

About

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

Enrollment

142 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≥95mmHg for drug-naïve patient)
Non-responder to 4 weeks treatment of losartan 100 mg monotherapy (sit DBP≥90mmHg)

Exclusion criteria

mean sit SBP≥200mmHg or mean sit DBP≥120mmHg at screening
mean sit SBP≥180 mmHg or mean sit DBP≥120mmHg after 4 weeks of losartan 100mg 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