Back to resultsVALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
valsartan
atenolol
hydrochlorothiazide
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Postmenopausal, women, overweight, hypertension, impaired, exercise, capacity, valsartan, atenolol, hydrochlorothiazide
Eligibility Criteria
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)
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171132
Brief Title
VALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Postmenopausal, women, overweight, hypertension, impaired, exercise, capacity, valsartan, atenolol, hydrochlorothiazide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valsartan
Intervention Type
Drug
Intervention Name(s)
atenolol
Intervention Type
Drug
Intervention Name(s)
hydrochlorothiazide
Primary Outcome Measure Information:
Title
Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in diastolic heart function after 26 weeks, measured by echocardiography
Title
Change from baseline in heart rate and blood pressure,
Title
during exercise testing after 26 weeks
Title
Change from baseline in heart size after 26 weeks, measured by echocardiography
Title
Change from baseline in quality of life measures after 26 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Investigative Centers
Country
Germany
Facility Name
Novartis Pharmaceuticals
City
Basel
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19300114
Citation
Dusing R, Handrock R, Klebs S, Tousset E, Vrijens B. Impact of supportive measures on drug adherence in patients with essential hypertension treated with valsartan: the randomized, open-label, parallel group study VALIDATE. J Hypertens. 2009 Apr;27(4):894-901. doi: 10.1097/HJH.0b013e328323f9be.
Results Reference
result
Learn more about this trial
VALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women
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