PROTEINURIAPhase 4NCT00241085
Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus
A Phase 4 study testing valsartan in people with PROTEINURIA and Hypertension, run by Novartis.
Trial summary
This is a study of whether valsartan affects levels of proteinuria in patients with type 2 diabetes and hypertension. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PROTEINURIA, Hypertension, Type 2 Diabetes
- What is being tested?
- valsartan
- How many people
- 392 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mild to moderate hypertension, Mild renal dysfunction, Type 2 diabetes,
Who cannot join
- Pregnant or breast feeding, Type 1 diabetes
- Other protocol criteria apply
About this study
Official title: A Multi-center, Double Blind, Randomized, Parallel Group Study to Evaluate the Effects of Valsartan on Proteinuria in Hypertensive Subjects With Type 2 Diabetes Mellitus
This is a study of whether valsartan affects levels of proteinuria in patients with type 2 diabetes and hypertension.
- Conditions
- PROTEINURIA, Hypertension, Type 2 Diabetes
- Being tested
- valsartan
- Keywords
- proteinuria, hypertension, valsartan, type 2 diabetes
- Medical subject headings
- Proteinuria, Hypertension, 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 urinary protein excretion after 30 weeks
Secondary outcomes (1)
Change from baseline in circulating markers of blood vessel inflammation, insulin resistance, serum creatinine, diabetic control, and proportion of patients who return to normalization of protein excretion after 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startNov 2002
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PROTEINURIAStudies 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
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241085
- Sponsor's protocol ID
- CVAL489A2417
- Status last verified
- Jun 2006
- First submitted
- 14 Oct 2005
- Last updated
- 8 Nov 2011
- Results posted
- No
Publications
Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
PubMed 38682786Weir MR, Hollenberg NK, Zappe DH, Meng X, Parving HH, Viberti G, Remuzzi G. Antihypertensive effects of double the maximum dose of valsartan in African-American patients with type 2 diabetes mellitus and albuminuria. J Hypertens. 2010 Jan;28(1):186-93. doi: 10.1097/HJH.0b013e328332bd61.
PubMed 19809363
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double Blind, Randomized, Parallel Group Study to Evaluate the Effects of Valsartan on Proteinuria in Hypertensive Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00241085
- Acronym / sponsor ID
- CVAL489A2417
- Conditions
- PROTEINURIA, Hypertension, Type 2 Diabetes
- Keywords
- proteinuria, hypertension, valsartan, type 2 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 18 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.
This is a study of whether valsartan affects levels of proteinuria in patients with type 2 diabetes and hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to moderate hypertension, Mild renal dysfunction, Type 2 diabetes,
Key exclusion criteria (2 listed)
- Pregnant or breast feeding, Type 1 diabetes
- Other protocol criteria 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 urinary protein excretion after 30 weeks
1 secondary outcome
Change from baseline in circulating markers of blood vessel inflammation, insulin resistance, serum creatinine, diabetic control, and proportion of patients who return to normalization of protein excretion after 30 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 8 Nov 2011.
- Derived from this study: PubMed 38682786Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.
- Derived from this study: PubMed 19809363Weir MR, Hollenberg NK, Zappe DH, Meng X, Parving HH, Viberti G, Remuzzi G. Antihypertensive effects of double the maximum dose of valsartan in African-American patients with type 2 diabetes mellitus and albuminuria. J Hypertens. 2010 Jan;28(1):186-93. doi: 10.1097/HJH.0b013e328332bd61.
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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 valsartan in people with PROTEINURIA and Hypertension, 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 1 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 8 Nov 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 urinary protein excretion after 30 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 NCT00241085, which also lists 2 linked publications.
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 8 Nov 2011.