HypertensionPhase 4STARNCT00234858
Tarka vs. Hyzaar in Patients With Metabolic Syndrome (STAR)
A Phase 4 study testing trandolapril/verapamil and (Hyzaar) losartan/hydrochlorothiazide in people with Hypertension and Metabolic Syndrome, run by Abbott.
Trial summary
The primary objective of this study is to determine whether impaired glucose tolerance is improved to a greater degree by Tarka than Hyzaar in subjects with metabolic syndrome Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension, Metabolic Syndrome
- What is being tested?
- trandolapril/verapamil and (Hyzaar) losartan/hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Apr 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metabolic syndrome
- Fasting blood glucose between 100 mg/dL and 125 mg/dL
- Hypertension
- One additional criteria, Exclusion 1
Who cannot join
- Subject has a current diagnosis of Type 1 or Type 2 diabetes mellitus.
- Subject has a hypersensitivity to ACE inhibitor, ARB, CCB, clonidine, methyldopa, hydralazine, or thiazide diuretic medication.
About this study
Official title: A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Hyzaar® on Glucose Tolerance in Subjects With Metabolic Syndrome
The primary objective of this study is to determine whether impaired glucose tolerance is improved to a greater degree by Tarka than Hyzaar in subjects with metabolic syndrome
- Conditions
- Hypertension, Metabolic Syndrome
- Being tested
- trandolapril/verapamil, (Hyzaar) losartan/hydrochlorothiazide
- Keywords
- Hypertension, Metabolic Syndrome, Tarka, Hyzaar
- 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.
trandolapril/verapamilDrug
Also called ABT-TARKA, Tarka
2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD
(Hyzaar) losartan/hydrochlorothiazideDrug
Also called Hyzaar, losartan/hydrochlorothiazide
50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: trandolapril/verapamil |
| 2 | Active comparator | Not described Receives: Drug: (Hyzaar) losartan/hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Glucose Tolerance
Measured: up to 1 year / 52 weeks
Secondary outcomes (1)
Changes in blood pressure (BP), pulse rate and BP control. HbA1c, insulin sensitivity, insulin release, albuminuria, lipid profile, AMBP, clinical safety labs and adverse events.
Measured: up to 1 year / 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startMar 2004
- Primary completionApr 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 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
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234858
- Sponsor's protocol ID
- M03-598
- Acronym
- STAR
- Status last verified
- Jun 2008
- First submitted
- 13 Sep 2005
- Last updated
- 15 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bakris G, Molitch M, Hewkin A, Kipnes M, Sarafidis P, Fakouhi K, Bacher P, Sowers J; STAR Investigators. Differences in glucose tolerance between fixed-dose antihypertensive drug combinations in people with metabolic syndrome. Diabetes Care. 2006 Dec;29(12):2592-7. doi: 10.2337/dc06-1373.
PubMed 17130190
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Hyzaar® on Glucose Tolerance in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00234858
- Acronym / sponsor ID
- STAR / M03-598
- Conditions
- Hypertension, Metabolic Syndrome
- Keywords
- Hypertension, Metabolic Syndrome, Tarka, Hyzaar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Apr 2006 (actual)
- First posted
- 10 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 primary objective of this study is to determine whether impaired glucose tolerance is improved to a greater degree by Tarka than Hyzaar in subjects with metabolic syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: trandolapril/verapamil |
| 2 | Active comparator | Drug: (Hyzaar) losartan/hydrochlorothiazide |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Metabolic syndrome
- Fasting blood glucose between 100 mg/dL and 125 mg/dL
- Hypertension
- One additional criteria, Exclusion 1
Key exclusion criteria (2 listed)
- Subject has a current diagnosis of Type 1 or Type 2 diabetes mellitus.
- Subject has a hypersensitivity to ACE inhibitor, ARB, CCB, clonidine, methyldopa, hydralazine, or thiazide diuretic medication.
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 |
|---|---|---|
| trandolapril/verapamilAlso: ABT-TARKA, Tarka2/180 mg QD with titration if needed at Week 4 to 4/240 mg QD | Drug | 1 |
| (Hyzaar) losartan/hydrochlorothiazideAlso: Hyzaar, losartan/hydrochlorothiazide50/12.5 mg QD with titration if needed at Week 4 to 100/25 mg QD | Drug | 2 |
Primary outcome
Oral Glucose Tolerance
Time frame: up to 1 year / 52 weeks
1 secondary outcome
Changes in blood pressure (BP), pulse rate and BP control. HbA1c, insulin sensitivity, insulin release, albuminuria, lipid profile, AMBP, clinical safety labs and adverse events.
Time frame: up to 1 year / 52 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 15 Jul 2008.
- Derived from this study: PubMed 17130190Bakris G, Molitch M, Hewkin A, Kipnes M, Sarafidis P, Fakouhi K, Bacher P, Sowers J; STAR Investigators. Differences in glucose tolerance between fixed-dose antihypertensive drug combinations in people with metabolic syndrome. Diabetes Care. 2006 Dec;29(12):2592-7. doi: 10.2337/dc06-1373.
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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.
Global Medical Information study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing trandolapril/verapamil and (Hyzaar) losartan/hydrochlorothiazide in people with Hypertension and Metabolic Syndrome, run by Abbott.
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 2 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 15 Jul 2008. 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?
Oral Glucose Tolerance (time frame: up to 1 year / 52 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 NCT00234858, 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 15 Jul 2008.