HypertensionPhase 4NCT00171132
VALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women
A Phase 4 study testing valsartan, atenolol and hydrochlorothiazide in people with Hypertension, run by Novartis at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- valsartan, atenolol and hydrochlorothiazide
- How many people
- 64 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2004to Aug 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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
- Being tested
- valsartan, atenolol, hydrochlorothiazide
- Keywords
- Postmenopausal, women, overweight, hypertension, impaired, exercise, capacity, valsartan, atenolol, hydrochlorothiazide
- Medical subject headings
- Hypertension, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
atenololDrug
hydrochlorothiazideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171132
- Sponsor's protocol ID
- CVAL489ADE21
- Status last verified
- Feb 2017
- First submitted
- 10 Sep 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
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.
PubMed 19300114
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00171132
- Acronym / sponsor ID
- CVAL489ADE21
- Conditions
- Hypertension
- Keywords
- Postmenopausal, women, overweight, hypertension, impaired, exercise, capacity, valsartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valsartan | Drug | – |
| atenolol | Drug | – |
| hydrochlorothiazide | Drug | – |
Primary outcome
Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Results publication: PubMed 19300114Dusing 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valsartan, atenolol and hydrochlorothiazide in people with Hypertension, run by Novartis at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in exercise capacity measured by oxygen consumption during exercise testing, after 26 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00171132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.