Safety and Efficacy of Valsartan Plus Hydrochlorothiazide and Amlodipine in Hypertensive Patients

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

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-09-30

Brief Summary

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A double-blind, active-controlled, randomized trial to compare Valsartan plus Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5 mg.

Study design: 2 weeks washout, 8 weeks treatment period.

Detailed Description

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Conditions

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Hypertension

Keywords

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AMPM, SBP, DBP, Valsartan plus Hydrochlorothiazide, Amlodipine, high blood pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Valsartan plus Hydrochlorothiazide (80mg/12.5mg)

Intervention Type DRUG

Amlodipine (5mg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female or male patient with age ≧ 18 years old.
* Patient with mild to moderate uncomplicated essential hypertension, and the blood pressure not adequately controlled on existing antihypertensive treatment.
* Patient with sitting systolic blood pressure (sSBP)/ sitting diastolic blood pressure (sDBP) ≦ 180/110 mmHg at screening visit.
* For non-diabetic patient, sitting systolic blood pressure (sSBP) ≧ 140 mmHg or sitting diastolic blood pressure (sDBP) ≧ 90 mmHg at baseline visit; for diabetic patient, sitting systolic blood pressure (sSBP) ≧ 130 mmHg or sitting diastolic blood pressure (sDBP) ≧ 80 mmHg at baseline visit.
* Patient or his/her legally acceptable representative has signed and dated the informed consent form.

Exclusion Criteria

* Known or suspected secondary hypertension.
* sSBP \> 180 mmHg or sDBP \> 110 mmHg at baseline visit.
* Patients taking more than two anti-hypertensive medications at the screening visit. (Fixed-dose combinations of two or more antihypertensive therapies will be counted as two or more antihypertensive medications.)
* Known NYHA functional class Chronic Heart Failure (CHF) III and IV.
* With a history of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 6 months, clinically significant valvular heart disease, or hepatic and/or renal dysfunction as defined by the following laboratory parameters
* SGPT (ALT) or SGOT (AST) \> two times upper the limit of normal range
* Serum creatinine \> 2.3 mg/dl or creatinine clearance \< 30 ml/min

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jeremiah CHAO, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan Univ

Locations

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National Taiwan University

Taipei, R.o.c, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CVAH631BTW02

Identifier Type: -

Identifier Source: org_study_id