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

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00426478
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-01-23
• Study First Submitted QC: 2007-01-23
• Study First Posted: 2007-01-24
• Study Completion: 2007-09
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-20
• Last Update Posted: 2008-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

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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/exclusion criteria may apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Taiwan University; 🇨🇳 Taipei, R.o.c, Taiwan