HypertensionPhase 4NCT00241150
Diva - The Effects Of 12 Weeks Of Treatment With High Dose Valsartan (320 Mg) To Amlodipine On Endothelial Function In Hypertensive Subjects With The Metabolic Syndrome
A Phase 4 study testing VALSARTAN in people with Hypertension and Metabolic Syndrome, run by Novartis.
Trial summary
A STUDY ON WHETHER AN ANTIHYPERTENSIVE MEDICATION PREVENTS DAMAGE TO WALLS OF VEINS IN FEMALE PATIENTS WITH THE METABOLIC SYNDROME (OVERWEIGHT AND OTHER DISORDERS). Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Metabolic Syndrome
- What is being tested?
- VALSARTAN
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Jan 2005
- 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet the following inclusion criteria at Visit 1, Visit 2 and Visit 3.
- Inclusion criteria for Group A (overweight postmenopausal females with high-normal blood pressure/ mild Stage I hypertension)
- Non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year.
- Mean blood pressure between 130 - 149 mm Hg systolic and/or 85 - 94 mm Hg diastolic
- When systolic blood pressure and diastolic blood pressure fall into different categories (high normal versus mild stage I hypertension), the higher category should be selected to classify or group the subject.
- Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2
- Subjects who agree not to alter their diet or exercise routine during the study and comply with study specific restrictions 24 hours prior to the next scheduled study visit
- Subjects who have read, signed and received a copy of the informed consent form prior to the initiation of any study procedures and who agree to participate in all aspects of the study
Who cannot join
- 1. Non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year.
- 2. Mean blood pressure between 90 - 129 mm Hg systolic and/or 50 - 84 mm Hg diastolic.
- 3. Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2
About this study
Official title: A Multicenter, Double Blind, Randomized Study With Two Parallel Groups Comparing The Effects Of 12 Weeks Of Treatment With High Dose Valsartan (320 Mg) To Amlodipine On Endothelial Function In Hypertensive Subjects With The Metabolic Syndrome
A STUDY ON WHETHER AN ANTIHYPERTENSIVE MEDICATION PREVENTS DAMAGE TO WALLS OF VEINS IN FEMALE PATIENTS WITH THE METABOLIC SYNDROME (OVERWEIGHT AND OTHER DISORDERS).
- Conditions
- Hypertension, Metabolic Syndrome
- Being tested
- VALSARTAN
- Keywords
- valsartan, hypertension, metabolic syndrome, endothelial function
- Medical subject headings
- Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VALSARTANDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline flow-mediated vasodilatation after 12 weeks
Secondary outcomes (5)
Change in baseline brachial artery flow after 12 weeks
Circulating markers of oxidation, inflammation, and fibrinolysis at baseline, 12 weeks
Adverse events and serious adverse events at each study visit for up to 12 weeks
Hematology, blood chemistries, and urine for up to 12 weeks
Vital signs, physical condition, and body weight for up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startNov 2002
- Primary completionJan 2005
- Study completionJan 2005
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
- 80 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
- NCT00241150
- Sponsor's protocol ID
- CVAL489A2416
- Status last verified
- Jun 2006
- First submitted
- 14 Oct 2005
- Last updated
- 8 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double Blind, Randomized Study With Two Parallel Groups Comparing The Effects Of 12 Weeks Of Treatment With High Dose Valsartan (320 Mg) To Amlodipine On Endothelial Function In Hypertensive Subjects With The Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00241150
- Acronym / sponsor ID
- CVAL489A2416
- Conditions
- Hypertension, Metabolic Syndrome
- Keywords
- valsartan, hypertension, metabolic syndrome, endothelial function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 18 Oct 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 ON WHETHER AN ANTIHYPERTENSIVE MEDICATION PREVENTS DAMAGE TO WALLS OF VEINS IN FEMALE PATIENTS WITH THE METABOLIC SYNDROME (OVERWEIGHT AND OTHER DISORDERS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must meet the following inclusion criteria at Visit 1, Visit 2 and Visit 3.
- Inclusion criteria for Group A (overweight postmenopausal females with high-normal blood pressure/ mild Stage I hypertension)
- Non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year.
- Mean blood pressure between 130 - 149 mm Hg systolic and/or 85 - 94 mm Hg diastolic
- Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2
Key exclusion criteria (3 listed)
- 1. Non-smoking female outpatients diagnosed as postmenopausal based on age (48 - 65 years) and self-reported absence of menstrual periods for at least one year.
- 2. Mean blood pressure between 90 - 129 mm Hg systolic and/or 50 - 84 mm Hg diastolic.
- 3. Body mass index greater than or equal to 26 but less than or equal to 41 kg/m2
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 | – |
Primary outcome
Change in baseline flow-mediated vasodilatation after 12 weeks
5 secondary outcomes
Change in baseline brachial artery flow after 12 weeks
Circulating markers of oxidation, inflammation, and fibrinolysis at baseline, 12 weeks
Adverse events and serious adverse events at each study visit for up to 12 weeks
Hematology, blood chemistries, and urine for up to 12 weeks
Vital signs, physical condition, and body weight for up to 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 8 Nov 2011.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VALSARTAN in people with Hypertension and Metabolic Syndrome, run by Novartis.
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 8 inclusion and 3 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 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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 in baseline flow-mediated vasodilatation 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 8 Nov 2011.