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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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amlodipine/losartan 5/100mg

Group Type EXPERIMENTAL

Amlodipine plus Losartan

Intervention Type DRUG

amlodipine/losartan 5/100mg q.d.

losartan 100mg

Group Type ACTIVE_COMPARATOR

Losartan

Intervention Type DRUG

losartan 100mg q.d.

Interventions

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Amlodipine plus Losartan

amlodipine/losartan 5/100mg q.d.

Intervention Type DRUG

Losartan

losartan 100mg q.d.

Intervention Type DRUG

Other Intervention Names

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Amosartan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No