HypertensionPhase 4NCT00241072
Clinical Trial To Evaluate The Effect Of Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance
A Phase 4 study testing valsartan in people with Hypertension and Impaired Glucose Tolerance, run by Novartis.
Trial summary
THE PURPOSE OF THIS STUDY IS TO DETERMINE IF 24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG) IMPROVES INSULIN SENSITIVITY IN SUBJECTS WITH HIGHER THAN NORMAL GLUCOSE LEVELS USING A TEST CALLED THE EUGLYCEMIC CLAMP. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Impaired Glucose Tolerance
- What is being tested?
- valsartan
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- history or presenting hypertension Elevated fasting blood glucose levels -
Who cannot join
- Pregnancy potential Diabetes mellitus
- Other criteria apply
- -
About this study
Official title: A Single Center, Open Label, Single Arm Trial To Evaluate The Effect Of Twenty Four Weeks Of Treatment With 80 Mg To 320 Mg Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance (Igt)
THE PURPOSE OF THIS STUDY IS TO DETERMINE IF 24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG) IMPROVES INSULIN SENSITIVITY IN SUBJECTS WITH HIGHER THAN NORMAL GLUCOSE LEVELS USING A TEST CALLED THE EUGLYCEMIC CLAMP.
- Conditions
- Hypertension, Impaired Glucose Tolerance
- Being tested
- valsartan
- Medical subject headings
- Hypertension, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline insulin sensitivity after 24 weeks
Secondary outcomes (5)
Change from baseline in the function of cells that line blood vessels after 24 weeks
Change from baseline in markers of vascular inflammation after 24 weeks
Adverse events and serious adverse events at each study visit for 24 weeks
Hematology, blood chemistries, and urine measurements for up to 24 weeks
Vital signs and physical examinations for up to 24 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 startSep 2002
- Primary completionJul 2005
- Study completionJul 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT00241072
- Sponsor's protocol ID
- CVAL489A2412
- Status last verified
- May 2012
- First submitted
- 14 Oct 2005
- Last updated
- 4 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Single Arm Trial To Evaluate The Effect Of Twenty Four Weeks Of Treatment With 80 Mg To 320 Mg Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance (Igt)
- ClinicalTrials.gov ID
- NCT00241072
- Acronym / sponsor ID
- CVAL489A2412
- Conditions
- Hypertension, Impaired Glucose Tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 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.
THE PURPOSE OF THIS STUDY IS TO DETERMINE IF 24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG) IMPROVES INSULIN SENSITIVITY IN SUBJECTS WITH HIGHER THAN NORMAL GLUCOSE LEVELS USING A TEST CALLED THE EUGLYCEMIC CLAMP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- history or presenting hypertension Elevated fasting blood glucose levels -
Key exclusion criteria (3 listed)
- Pregnancy potential Diabetes mellitus
- Other criteria apply
- -
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 |
|---|---|---|
| valsartan24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG) | Drug | – |
Primary outcome
Change from baseline insulin sensitivity after 24 weeks
5 secondary outcomes
Change from baseline in the function of cells that line blood vessels after 24 weeks
Change from baseline in markers of vascular inflammation after 24 weeks
Adverse events and serious adverse events at each study visit for 24 weeks
Hematology, blood chemistries, and urine measurements for up to 24 weeks
Vital signs and physical examinations for up to 24 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 4 May 2012.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valsartan in people with Hypertension and Impaired Glucose Tolerance, 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 1 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 4 May 2012. 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 from baseline insulin sensitivity after 24 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 4 May 2012.