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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00426478
First received: January 23, 2007
Last updated: August 20, 2008
Last verified: August 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 80
Study Start Date: November 2006
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426478

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

No publications provided

ClinicalTrials.gov Identifier: NCT00426478     History of Changes
Other Study ID Numbers: CVAH631BTW02
Study First Received: January 23, 2007
Last Updated: August 20, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by Novartis:
AMPM, SBP, DBP, Valsartan plus Hydrochlorothiazide, Amlodipine, high blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Amlodipine
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014