NCT00171132

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Aug 2004

Typical duration for phase_4 hypertension

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

3 years

First QC Date

September 10, 2005

Last Update Submit

February 21, 2017

Conditions

Hypertension

Keywords

Postmenopausalwomenoverweighthypertensionimpairedexercisecapacityvalsartanatenololhydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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

Interventions

valsartanDRUG
atenololDRUG
hydrochlorothiazideDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Investigative Centers, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 19300114RESULT

MeSH Terms

Conditions

HypertensionOverweightMotor Activity

Interventions

ValsartanAtenololHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

August 1, 2004

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

CH(1)DE(1)