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

The Comparison of the Antihypertensive Efficacy and Tolerability Between Valsartan Plus Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5mg in the Essential Hypertensive Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00426478

Enrollment

Registered

2007-01-24

Start date

2006-11-30

Completion date

2007-09-30

Last updated

2008-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

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

Brief summary

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.

Interventions

DRUGValsartan plus Hydrochlorothiazide (80mg/12.5mg)

DRUGAmlodipine (5mg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks treatment	—

Secondary

Measure	Time frame
Change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks treatment	—
Change from baseline in Ambulatory Blood Pressure Measurement (ABPM) parameters after 8 weeks treatment	—

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026