HypertensionPhase 4TANDEMNCT00234871
Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM)
A Phase 4 study testing trandolapril/verapamil and Lotrel (amlodipine/benazepril) in people with Hypertension and Diabetes, run by Abbott.
Trial summary
The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes, Proteinuria
- What is being tested?
- trandolapril/verapamil and Lotrel (amlodipine/benazepril)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes
- Hypertension
- Albuminuria
Who cannot join
- Type 1 DM.
- Subject has severe hepatic dysfunction at Screening as determined by liver function tests:
- Bilirubin > 2.0 mg/dL.
- ALT and/or AST > 3 times the upper limit of normal.
- Subject has poorly controlled diabetes, based on HbA1c > 10% at Screening.
- Subject has non-diabetic renal disease.
- Subject has a hypersensitivity to ACE inhibitor, CCB, torsemide or sulfonylureas.
About this study
Official title: A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Lotrel® on Albuminuria in Hypertensive, Type 2 Diabetic Subjects With Diabetic Nephropathy
The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy
- Conditions
- Hypertension, Diabetes, Proteinuria
- Being tested
- trandolapril/verapamil, Lotrel (amlodipine/benazepril)
- Keywords
- Hypertension, Diabetes, Proteinuria, Tarka, Lotrel
- Medical subject headings
- Hypertension, Diabetes Mellitus, Proteinuria
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 forced titration after 4 weeks to 4/240 mg QD
Lotrel (amlodipine/benazepril)Drug
5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: trandolapril/verapamil |
| 2 | Active comparator | Not described Receives: Drug: Lotrel (amlodipine/benazepril) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in urinary albumin:creatinine ratio
Measured: 36 weeks
Secondary outcomes (1)
Changes in blood pressure (BP), BP control, ABPM, proteinuria, GFR lipid parameters, glycemic control, quality of life, CRP, oxidative stress markers, clinical safety labs and adverse events.
Measured: 36 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 startJan 2004
- Primary completionMar 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
- None (open label)
- Enrolment
- 357 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
- NCT00234871
- Sponsor's protocol ID
- M03-599
- Acronym
- TANDEM
- Status last verified
- Jul 2008
- First submitted
- 13 Sep 2005
- Last updated
- 15 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
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 Lotrel® on Albuminuria in Hypertensive, Type 2 Diabetic Subjects With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00234871
- Acronym / sponsor ID
- TANDEM / M03-599
- Conditions
- Hypertension, Diabetes, Proteinuria
- Keywords
- Hypertension, Diabetes, Proteinuria, Tarka, Lotrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Mar 2005 (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 if trandolapril/verapamil (Tarka®) is superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy
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: Lotrel (amlodipine/benazepril) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetes
- Hypertension
- Albuminuria
Key exclusion criteria (7 listed)
- Type 1 DM.
- Subject has severe hepatic dysfunction at Screening as determined by liver function tests:
- Subject has non-diabetic renal disease.
- Subject has a hypersensitivity to ACE inhibitor, CCB, torsemide or sulfonylureas.
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 forced titration after 4 weeks to 4/240 mg QD | Drug | 1 |
| Lotrel (amlodipine/benazepril)5/10 mg QD with forced titration after 4 weeks to 10/20 mg QD | Drug | 2 |
Primary outcome
Changes in urinary albumin:creatinine ratio
Time frame: 36 weeks
1 secondary outcome
Changes in blood pressure (BP), BP control, ABPM, proteinuria, GFR lipid parameters, glycemic control, quality of life, CRP, oxidative stress markers, clinical safety labs and adverse events.
Time frame: 36 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.
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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 Lotrel (amlodipine/benazepril) in people with Hypertension and Diabetes, 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 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 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?
Changes in urinary albumin:creatinine ratio (time frame: 36 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 15 Jul 2008.