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Trial record 33 of 101 for:    AMLODIPINE AND VALSARTAN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00426478
Recruitment Status : Completed
First Posted : January 24, 2007
Last Update Posted : August 22, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Valsartan plus Hydrochlorothiazide (80mg/12.5mg) Drug: Amlodipine (5mg) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Comparison of the Antihypertensive Efficacy and Tolerability Between Valsartan Plus Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5mg in the Essential Hypertensive Patients
Study Start Date : November 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks treatment

Secondary Outcome Measures :
  1. Change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks treatment
  2. Change from baseline in Ambulatory Blood Pressure Measurement (ABPM) parameters after 8 weeks treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00426478

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National Taiwan University
Taipei, R.o.c, Taiwan, 100
Sponsors and Collaborators
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Principal Investigator: Jeremiah CHAO, MD National Taiwan Univ

Layout table for additonal information Identifier: NCT00426478    
Other Study ID Numbers: CVAH631BTW02
First Posted: January 24, 2007    Key Record Dates
Last Update Posted: August 22, 2008
Last Verified: August 2008
Keywords provided by Novartis:
AMPM, SBP, DBP, Valsartan plus Hydrochlorothiazide, Amlodipine, high blood pressure
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Natriuretic Agents
Sodium Chloride Symporter Inhibitors