HypertensionPhase 4NCT00171756
Study to Compare the Effect of Valsartan vs Atenolol on Pro-thrombotic State in Hypertensive Patients.
A Phase 4 study testing valsartan/atenolol in people with Hypertension, run by Novartis at 1 site in Switzerland.
Trial summary
A study to compare the effects of Diovan or Atenolol taken for 12 weeks on platelet function of patients who have mild to moderately severe hypertension Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- valsartan/atenolol
- How many people
- 92 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2004to Mar 2006
- 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 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male or female, aged between 18 - 75 years of age inclusively.
- Mild to moderate hypertension (MSDBP >= 95 and >= 110 mmHg and / or MSSBP >140mm Hg) at visit 1, requiring pharmacological intervention. For newly diagnosed patients, hypertensive blood pressure values must be noted on at least two successive examinations prior to entry into the study. In addition, patients must require therapy despite having been following dietary \& lifestyle advice for at least 3 months.
- Written informed consent to participate in the study, prior to any study procedures.
- Ability to communicate and comply with all study requirements
Who cannot join
- o Uncontrolled hypertension defined as seated blood pressure of either systolic BP >180 mmHg and/or diastolic BP >110mmHg.
- Clinically significant laboratory abnormalities that may interfere with the assessment of safety and/or efficacy of the study drug
- Patients with severe medical condition(s) that in the view of the investigator may prohibit participation in the study
- Renal artery stenosis
- Diabetes Mellitus
- Any condition resulting from or leading to platelet or clotting abnormalities (eg. hemophilia, von Willebrand's disease).
Show all 11Show fewer
- History of a vascular event or intervention (e.g. MI, PTCA or CABG) within 6 months preceding the study.
- History of clinically significant angina, LVH, transient ischemic attack, stroke, intermittent claudication, deep vein thrombosis (DVT), pulmonary embolism or peripheral vascular disease.
- Uncontrolled atrial fibrillation (>100 b.p.m. at rest) or other conditions which may require anti-aggregant or anti-vitamin K therapies.
- Clinical evidence of congestive heart failure.
- Evidence of second or third degree heart block or sick sinus syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Double-dummy, Multi-centre, Randomized, Active Controlled, Parallel Group Pilot Trial to Compare the Effects of Valsartan and Atenolol on the Pro-thrombotic State in Patients With Mild to Moderate Hypertension.
A study to compare the effects of Diovan or Atenolol taken for 12 weeks on platelet function of patients who have mild to moderately severe hypertension
- Conditions
- Hypertension
- Being tested
- valsartan/atenolol
- Keywords
- hypertension, valsartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartan/atenololDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in a clinical laboratory measurement of a blood clotting factor after 12 weeks
Secondary outcomes (2)
Change from baseline in clinical laboratory measurements of blood clotting factors, including platelet activation, thrombosis, fibrinolysis, anticoagulation after 12 weeks
Blood pressure of 140/85 mmHg or lower after 12 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 startJun 2004
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171756
- Sponsor's protocol ID
- CVAL489AGB09
- Status last verified
- Feb 2017
- First submitted
- 13 Sep 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
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 Double-blind, Double-dummy, Multi-centre, Randomized, Active Controlled, Parallel Group Pilot Trial to Compare the Effects of Valsartan and Atenolol on the Pro-thrombotic State in Patients With Mild to Moderate Hypertension.
- ClinicalTrials.gov ID
- NCT00171756
- Acronym / sponsor ID
- CVAL489AGB09
- Conditions
- Hypertension
- Keywords
- hypertension, valsartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (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.
A study to compare the effects of Diovan or Atenolol taken for 12 weeks on platelet function of patients who have mild to moderately severe hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged between 18 - 75 years of age inclusively.
- Mild to moderate hypertension (MSDBP >= 95 and >= 110 mmHg and / or MSSBP >140mm Hg) at visit 1, requiring pharmacological intervention. For newly diagnosed patients, hypertensive blood pressure values must be noted on at least two successive examinations prior to entry into the study. In addition, patients must require therapy despite having been following dietary \& lifestyle advice for at least 3 months.
- Written informed consent to participate in the study, prior to any study procedures.
- Ability to communicate and comply with all study requirements
Key exclusion criteria (11 listed)
- o Uncontrolled hypertension defined as seated blood pressure of either systolic BP >180 mmHg and/or diastolic BP >110mmHg.
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/atenolol | Drug | – |
Primary outcome
Change from baseline in a clinical laboratory measurement of a blood clotting factor after 12 weeks
2 secondary outcomes
Change from baseline in clinical laboratory measurements of blood clotting factors, including platelet activation, thrombosis, fibrinolysis, anticoagulation after 12 weeks
Blood pressure of 140/85 mmHg or lower after 12 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.
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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 study director
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valsartan/atenolol in people with Hypertension, run by Novartis at 1 site in Switzerland.
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 4 inclusion and 11 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 1 site in 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 a clinical laboratory measurement of a blood clotting factor after 12 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 7 Nov 2026.