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Trial record 44 of 116 for:    Atenolol

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

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: NCT00171132
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: valsartan Drug: atenolol Drug: hydrochlorothiazide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : August 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

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

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

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:   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)

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): NCT00171132

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

Additional Information:
Publications of Results:
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Responsible Party: Novartis Identifier: NCT00171132     History of Changes
Other Study ID Numbers: CVAL489ADE21
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by Novartis:
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Body Weight
Signs and Symptoms
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Anti-Arrhythmia Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents