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VALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: September 10, 2005
Last updated: February 21, 2017
Last verified: February 2017
The purpose of the study is to show that valsartan compared to atenolol has favorable effects on exercise capacity, quality of life, diastolic function and elevated blood pressure in hypertensive postmenopausal overweight women with impaired exercise tolerance despite normal left ventricular ejection fraction (LVEF).

Condition Intervention Phase
Drug: valsartan
Drug: atenolol
Drug: hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
Official Title: A 26-week Double-blind, Randomized, Multicenter Parallel-group Trial to Compare the Effects of Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women With Impaired Exercise Tolerance

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks

Secondary Outcome Measures:
  • Change from baseline in diastolic heart function after 26 weeks, measured by echocardiography
  • Change from baseline in heart rate and blood pressure,
  • during exercise testing after 26 weeks
  • Change from baseline in heart size after 26 weeks, measured by echocardiography
  • Change from baseline in quality of life measures after 26 weeks

Enrollment: 64
Study Start Date: August 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female

Inclusion Criteria:

  • Body mass index (BMI) must be ≥ 27 and < 35
  • Symptoms of impaired exercise capacity (e.g. who report shortness of breath on exertion when questioned) reported at Visit 1 or patients who have a history of shortness of breath which improved under diuretic therapy
  • LV ejection fraction must be > 45% measured by echocardiography at Visit 2.
  • Impaired exercise capacity measured by VO2max at Visit 4:

VO2max >14 and < 22 ml ⋅kg-1 ⋅min-1

Exclusion Criteria:

  • Mean sitting diastolic blood pressure (MSDBP) ≥ 110 mmHg and/or Mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg
  • LVEF ≤ 45 %
  • Inability to completely discontinue all previous antihypertensive medications safely for the duration of the study
  • Heavy smokers (>20 cigarettes/day)
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Please refer to this study by its identifier: NCT00171132

Investigative Centers, Germany
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Identifier: NCT00171132     History of Changes
Other Study ID Numbers: CVAL489ADE21
Study First Received: September 10, 2005
Last Updated: February 21, 2017

Keywords provided by Novartis:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Body Weight
Signs and Symptoms
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on May 24, 2017