Status:
COMPLETED
VALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 post...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00171132
Start Date
August 1 2004
End Date
August 1 2007
Last Update
February 23 2017
Active Locations (2)
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1
Investigative Centers, Germany
2
Novartis Pharmaceuticals
Basel, Switzerland