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

NCT ID: NCT00171132

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2007-08-31

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).

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

valsartan

Intervention Type: DRUG

atenolol

Intervention Type: DRUG

hydrochlorothiazide

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Investigative Centers, , Germany

Novartis Pharmaceuticals

Basel, , Switzerland

Countries

Germany; Switzerland

References

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.

Reference Type: RESULT

PMID: 19300114 (View on PubMed)

Other Identifiers

CVAL489ADE21

Identifier Type: -

Identifier Source: org_study_id