HypertensionPhase 4NCT00171119
A Study in Patients With Diabetes Mellitus Type II of the Effect on Albuminuria of 24 Week Treatment With Valsartan, Benazepril, and Valsartan+Benazepril
A Phase 4 study testing valsartan in people with Hypertension and Diabetic Nephropathy, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in Type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Hypertension, Diabetic Nephropathy
- What is being tested?
- valsartan
- How many people
- 81 participants
- Where
- 1 siteSwitzerland
- 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 35 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- male or female patients aged 35-75 years with type 2 diabetes mellitus and recent evidence of persistent microalbuminuria
- patients with a median (of 3 samples) timed overnight UAER in the microalbuminuric range of 20-200 g/min in the formal screening period prior to entry
- patients who give written, signed, informed consent.
- patients with/without mild /moderate hypertension.
- patients who are not on hypertensive treatment, or if they are already on treatment, those who accept to enter a 3 weeks no-treatment wash-out period before switching their treatment.
- patients without any accompanying systemic disease
Who cannot join
- pregnant or nursing women, or women of childbearing potential not using an acceptable method of contraception
- patients with type I diabetes mellitus defined by onset below the age of 35 years and requiring insulin within the first year after diagnosis
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 24-Week Study to Assess Blood Pressure Independent Effects of Valsartan Treatment, Benazepril Treatment and Combination of Both Valsartan and Benazepril Treatment on Urinary Albumin Excretion Rate With Type II Diabetes Mellitus and Microalbuminuria
The purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in Type 2 diabetic patients.
- Conditions
- Hypertension, Diabetic Nephropathy
- Being tested
- valsartan
- Keywords
- HYPERTENSION, DIABETES MELLITUS TYPE II, VALSARTAN, BENAZAPRIL
- Medical subject headings
- Hypertension, Diabetic Nephropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in urine albumin excretion rate after 24 weeks
Secondary outcomes (2)
Change from baseline in urine albumin excretion rate after 24 weeks in those patients with blood pressure greater than 140/90, or who had previously taken blood pressure medicine, at study entry
Percent of patients returning to normal urine albumin excretion rate after 24 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 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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171119
- Sponsor's protocol ID
- CVAL489ATR05
- Status last verified
- Dec 2008
- First submitted
- 10 Sep 2005
- Last updated
- 17 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week Study to Assess Blood Pressure Independent Effects of Valsartan Treatment, Benazepril Treatment and Combination of Both Valsartan and Benazepril Treatment on Urinary Albumin Excretion Rate With Type II Diabetes Mellitus and Microalbuminuria
- ClinicalTrials.gov ID
- NCT00171119
- Acronym / sponsor ID
- CVAL489ATR05
- Conditions
- Hypertension, Diabetic Nephropathy
- Keywords
- HYPERTENSION, DIABETES MELLITUS TYPE II, VALSARTAN, BENAZAPRIL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Mar 2005 (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 purpose of this study is to evaluate the efficacy of valsartan, benazepril or the combination of both in reduction of microalbuminuria in Type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male or female patients aged 35-75 years with type 2 diabetes mellitus and recent evidence of persistent microalbuminuria
- patients with a median (of 3 samples) timed overnight UAER in the microalbuminuric range of 20-200 g/min in the formal screening period prior to entry
- patients who give written, signed, informed consent.
- patients with/without mild /moderate hypertension.
- patients who are not on hypertensive treatment, or if they are already on treatment, those who accept to enter a 3 weeks no-treatment wash-out period before switching their treatment.
Key exclusion criteria (3 listed)
- pregnant or nursing women, or women of childbearing potential not using an acceptable method of contraception
- patients with type I diabetes mellitus defined by onset below the age of 35 years and requiring insulin within the first year after diagnosis
- Other protocol-defined exclusion criteria may 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 |
|---|---|---|
| valsartan | Drug | – |
Primary outcome
Change from baseline in urine albumin excretion rate after 24 weeks
2 secondary outcomes
Change from baseline in urine albumin excretion rate after 24 weeks in those patients with blood pressure greater than 140/90, or who had previously taken blood pressure medicine, at study entry
Percent of patients returning to normal urine albumin excretion rate after 24 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 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.
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 in people with Hypertension and Diabetic Nephropathy, run by Novartis Pharmaceuticals at 1 site in Switzerland.
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 6 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: stopped early, as of the sponsor's last update on 17 Dec 2008. 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 Switzerland. 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 was stopped early. Results are not available in the source record.
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 urine albumin excretion rate 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 17 Dec 2008.