METABOLIC SYNDROMEPhase 4NCT00170937
A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan (320 mg) and Hydrochlorothiazide (25 mg) Combined and Alone, in Patients With Metabolic Syndrome
A Phase 4 study testing valsartan plus hydrochlorothiazide in people with METABOLIC SYNDROME and HYPERTENSION, run by Novartis at 1 site in United States.
Trial summary
The metabolic syndrome is a classification for patients with a constellation of risk factors which may include abdominal obesity, hypertension, elevated blood lipids and sugar. Three or more of these factors together constitute the metabolic syndrome and place these patients at a greater risk for the development of… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- METABOLIC SYNDROME, HYPERTENSION, PRE-HYPERTENSION
- What is being tested?
- valsartan plus hydrochlorothiazide
- How many people
- 507 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Waist circumference: males > 40", females > 35 "
- MSSBP ≥ 130 mmHg but ≤ 160 mmHg and a MSDBP ≥ 85 mmHg but ≤ 100 mmHg
- At least one of the following criteria: - Fasting plasma glucose between 5.9 and 6.9 mmol/L; - Serum triglycerides > 150 mg/dL; - LDL Cholesterol: - < 40 mg/dL males; - < 50 mg/dL females
Who cannot join
- MSSBP> 180 mmHg or MSDBP > 110 mmHg
- Inability to discontinue all prior antihypertensives for a period of 4 weeks.
- History of diabetes
- History of stroke, transient ischemic attack or myocardial infarction.
- Significant weight change > 10 lbs during screening period
- Patients taking a diuretic for 3 months prior to screening.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan and Hydrochlorothiazide Combined and Alone, in Patients With Metabolic Syndrome
The metabolic syndrome is a classification for patients with a constellation of risk factors which may include abdominal obesity, hypertension, elevated blood lipids and sugar. Three or more of these factors together constitute the metabolic syndrome and place these patients at a greater risk for the development of diabetes and cardiovascular diseases. The purpose of this study is to determine whether two common drugs to lower blood pressure, whether used separately or in combination, have different effects on blood sugar levels in patients diagnosed with the metabolic syndrome.
- Conditions
- METABOLIC SYNDROME, HYPERTENSION, PRE-HYPERTENSION
- Being tested
- valsartan plus hydrochlorothiazide
- Keywords
- METABOLIC SYNDROME, VALSARTAN, HYDROCHLOROTHIAZIDE, HYPERTENSION,
- Medical subject headings
- Metabolic Syndrome, Hypertension, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartan plus hydrochlorothiazideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in insulin sensitivity after 16 weeks
Secondary outcomes (5)
Change from baseline in markers of inflammation and thrombosis after 16 weeks
Change from baseline in fasting plasma glucose and fasting insulin after 16 weeks
Change from baseline in lipid profile after 16 weeks
Change from baseline in a measurement of beta cell function after 16 weeks
Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 16 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 startNov 2004
- Primary completionMar 2006
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 METABOLIC SYNDROMEStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 507 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170937
- Sponsor's protocol ID
- CVAL489A2426
- Status last verified
- Nov 2016
- First submitted
- 10 Sep 2005
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Zappe DH, Sowers JR, Hsueh WA, Haffner SM, Deedwania PC, Fonseca VA, Keeling L, Sica DA. Metabolic and antihypertensive effects of combined angiotensin receptor blocker and diuretic therapy in prediabetic hypertensive patients with the cardiometabolic syndrome. J Clin Hypertens (Greenwich). 2008 Dec;10(12):894-903. doi: 10.1111/j.1751-7176.2008.00054.x.
PubMed 19120715
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan and Hydrochlorothiazide Combined and Alone, in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00170937
- Acronym / sponsor ID
- CVAL489A2426
- Conditions
- METABOLIC SYNDROME, HYPERTENSION, PRE-HYPERTENSION
- Keywords
- METABOLIC SYNDROME, VALSARTAN, HYDROCHLOROTHIAZIDE, HYPERTENSION,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 507 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary 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.
The metabolic syndrome is a classification for patients with a constellation of risk factors which may include abdominal obesity, hypertension, elevated blood lipids and sugar. Three or more of these factors together constitute the metabolic syndrome and place these patients at a greater risk for the development of diabetes and cardiovascular diseases. The purpose of this study is to determine whether two common drugs to lower blood pressure, whether used separately or in combination, have different effects on blood sugar levels in patients diagnosed with the metabolic syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Waist circumference: males > 40", females > 35 "
- MSSBP ≥ 130 mmHg but ≤ 160 mmHg and a MSDBP ≥ 85 mmHg but ≤ 100 mmHg
- At least one of the following criteria: - Fasting plasma glucose between 5.9 and 6.9 mmol/L; - Serum triglycerides > 150 mg/dL; - LDL Cholesterol: - < 40 mg/dL males; - < 50 mg/dL females
Key exclusion criteria (7 listed)
- MSSBP> 180 mmHg or MSDBP > 110 mmHg
- Inability to discontinue all prior antihypertensives for a period of 4 weeks.
- History of diabetes
- History of stroke, transient ischemic attack or myocardial infarction.
- Significant weight change > 10 lbs during screening period
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 plus hydrochlorothiazide | Drug | – |
Primary outcome
Change from baseline in insulin sensitivity after 16 weeks
5 secondary outcomes
Change from baseline in markers of inflammation and thrombosis after 16 weeks
Change from baseline in fasting plasma glucose and fasting insulin after 16 weeks
Change from baseline in lipid profile after 16 weeks
Change from baseline in a measurement of beta cell function after 16 weeks
Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 16 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 18 Nov 2016.
- Results publication: PubMed 19120715Zappe DH, Sowers JR, Hsueh WA, Haffner SM, Deedwania PC, Fonseca VA, Keeling L, Sica DA. Metabolic and antihypertensive effects of combined angiotensin receptor blocker and diuretic therapy in prediabetic hypertensive patients with the cardiometabolic syndrome. J Clin Hypertens (Greenwich). 2008 Dec;10(12):894-903. doi: 10.1111/j.1751-7176.2008.00054.x.
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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
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 plus hydrochlorothiazide in people with METABOLIC SYNDROME and HYPERTENSION, run by Novartis at 1 site in United States.
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 3 inclusion and 7 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 18 Nov 2016. 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 United States. 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 insulin sensitivity after 16 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 NCT00170937, 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 18 Nov 2016.