AlbuminuriaPhase 4NCT00136773
Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing amlodipine/benazepril in people with Albuminuria, run by Novartis.
Trial summary
Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Albuminuria
- What is being tested?
- amlodipine/benazepril
- How many people
- 332 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Nov 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 21 to 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- Mild to moderate hypertension
- Type 2 diabetes mellitus
- Presence of protein in the urine (albuminuria)
Who cannot join
- Kidney disease not caused by diabetes or hypertension
- Renal artery stenosis
- Myocardial infarction or stroke within the last 6 months
- Type 1 diabetes mellitus
- Pregnant or lactating females
- Cancer within the last 5 years
About this study
Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. This study will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary protein in hypertensive subjects with type 2 diabetes mellitus.
- Conditions
- Albuminuria
- Being tested
- amlodipine/benazepril
- Keywords
- Albuminuria, Type 2 diabetes mellitus, Hypertension
- Medical subject headings
- Albuminuria, Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlodipine/benazeprilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the urine albumin/creatinine ratio after 52 weeks
Secondary outcomes (5)
Percentage of patients who have progressed to diabetic kidney disease (urine albumin/creatinine ratio ≥ 300 µg/mg creatinine) after 52 weeks
Change from baseline in the ratio of urine albumin/creatinine ratio an estimate of kidney function after 52 weeks
Change from baseline in insulin resistance after 52 weeks
Change from baseline in urine albumin secretion after 52 weeks
Change from baseline in a marker of heart failure after 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startApr 2003
- Primary completionOct 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlbuminuriaStudies 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
- 332 participants (actual)
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
- NCT00136773
- Sponsor's protocol ID
- CCIB002FUS12
- Status last verified
- Mar 2008
- First submitted
- 25 Aug 2005
- Last updated
- 9 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00136773
- Acronym / sponsor ID
- CCIB002FUS12
- Conditions
- Albuminuria
- Keywords
- Albuminuria, Type 2 diabetes mellitus, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 29 Aug 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.
Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. This study will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary protein in hypertensive subjects with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to moderate hypertension
- Type 2 diabetes mellitus
- Presence of protein in the urine (albuminuria)
Key exclusion criteria (6 listed)
- Kidney disease not caused by diabetes or hypertension
- Renal artery stenosis
- Myocardial infarction or stroke within the last 6 months
- Type 1 diabetes mellitus
- Pregnant or lactating females
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 |
|---|---|---|
| amlodipine/benazepril | Drug | – |
Primary outcome
Change from baseline in the urine albumin/creatinine ratio after 52 weeks
5 secondary outcomes
Percentage of patients who have progressed to diabetic kidney disease (urine albumin/creatinine ratio ≥ 300 µg/mg creatinine) after 52 weeks
Change from baseline in the ratio of urine albumin/creatinine ratio an estimate of kidney function after 52 weeks
Change from baseline in insulin resistance after 52 weeks
Change from baseline in urine albumin secretion after 52 weeks
Change from baseline in a marker of heart failure after 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 9 Mar 2011.
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Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
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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 amlodipine/benazepril in people with Albuminuria, 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 3 inclusion and 6 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 9 Mar 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 from baseline in the urine albumin/creatinine ratio after 52 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 9 Mar 2011.