Efficacy and Safety of Amlodipine and 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

PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-12-31

Brief Summary

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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.

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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

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Amlodipine plus Losartan

amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg

Intervention Type DRUG

Amlodipine

amlodipine 5mg, 10mg

Intervention Type DRUG

Losartan

Losartan 50mg, 100mg

Intervention Type DRUG

Other Intervention Names

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Amosartan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No