HypertensionPhase 4NCT00171600
Antialbuminuric Effects of Valsartan and Lisinopril
A Phase 4 study testing VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ in people with Hypertension and Early Diabetic Nephropathy, run by Novartis at 1 site in Switzerland.
Trial summary
Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), open label, parallel group, 20 weeks follow-up. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hypertension, Early Diabetic Nephropathy
- What is being tested?
- VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2005to Jan 2007
- 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 40 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male or female outpatients aged 40-75 years,
- Chronic nephropathy, as defined by a serum creatinine concentration of > 1.3 mg/dL or calculated glomerular filtration rate of > 30 mL/min/1.73 m2.
- Persistent albuminuria, as defined by urinary albumin excretion exceeding 20 mg/ 24 h but not > 1000 mg/ 24h. (for a minimum of three months).
- Hypertensive patients not adequately controlled with or without treatment (controlled: <130/80 mmHg).
- Written informed consent to participate in the study prior to any study procedures.
Who cannot join
- Immediate need for renal replacement therapy.
- Treatment resistant oedema or nephrotic syndrome.
- Need for treatment with corticosteroids, non-steroidal antiinflammatory drugs, or immunosuppressive drugs.
- Albuminuria greater than 1000mg /24h and or less than 20mg/24h.
- Total cholesterol < 135mg/dl or not need for statins treatment.
- Renovascular hypertension
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- Malignant hypertension
- MI, cerebrovascular accident within last year, severe peripheral vascular disease, CHF, chronic hepatic disease.
- Angiotensin converting enzyme inhibitors and angiotensin II receptors blockers within one month prior to randomization.
- A serum creatinine concentration >265 umol/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative, Open Multicenter Trial Assessing the Effect on Albumin Excretion Rate of 320mg Valsartan (With or Without HCTZ) vs 40mg Lisinopril (With or Without HCTZ) on Hypertensive Patients With Diabetic and Non-diabetic Nephropathy and Albuminuria
Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), open label, parallel group, 20 weeks follow-up.
Objective: To evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril vs combo treatment in non-diabetic and diabetic patients.
Read more
Hypothesis: Combo treatment reduces microalbuminuria and the albumin/creatinine ratio more than monotherapies..
Design: Multicentric, randomized, open label, parallel group, active controlled.
Dose / regimen: Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20
Primary Endpoint: Antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan versus lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of follow-up. Description % of change in albuminuria from baseline at 20 weeks.
Secondary Endpoint : To investigate the effect of 5 months treatment with valsartan,lisinopril and valsartan versus lisinopril in GFR (Cl creatinine), also to investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus lisinopril on blood pressure and the effect on left ventricular mass index using electrocardiogram and Cornell-Sokolow method.
- Conditions
- Hypertension, Early Diabetic Nephropathy
- Being tested
- VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ
- Keywords
- valsartan, lisinopril, albuminuria, diabetic nephropathy
- Medical subject headings
- Hypertension, Diabetic Nephropathies, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VALSARTAN, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZDrug
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 from collected urine samples, after 16 and 20 weeks
Secondary outcomes (5)
Blood pressure less than 130/80 mmHg after 16 and 20 weeks of treatment
Change from baseline 48-hour ambulatory blood pressure, and blood pressure less than 130/80 mmHg after 16 and 20 weeks of treatment
Blood pressure less than 130/80 mmHg at night, measured by 48-hour ambulatory blood pressure monitoring, after 16 and 20 weeks of treatment
Change from baseline in size of left heart ventricle by electrocardiogram (ECG) after 20 weeks
Change from baseline in kidney function after 16 and 20 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 startJul 2005
- Primary completionJan 2007
- Study completionJan 2007
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
- 54 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
- NCT00171600
- Sponsor's protocol ID
- CVAL489AES15
- Status last verified
- Nov 2011
- First submitted
- 12 Sep 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 38682786
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
- Comparative, Open Multicenter Trial Assessing the Effect on Albumin Excretion Rate of 320mg Valsartan (With or Without HCTZ) vs 40mg Lisinopril (With or Without HCTZ) on Hypertensive Patients With Diabetic and Non-diabetic Nephropathy and Albuminuria
- ClinicalTrials.gov ID
- NCT00171600
- Acronym / sponsor ID
- CVAL489AES15
- Conditions
- Hypertension, Early Diabetic Nephropathy
- Keywords
- valsartan, lisinopril, albuminuria, diabetic nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 54 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (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.
Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), open label, parallel group, 20 weeks follow-up.
Objective: To evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril vs combo treatment in non-diabetic and diabetic patients.
Hypothesis: Combo treatment reduces microalbuminuria and the albumin/creatinine ratio more than monotherapies..
Design: Multicentric, randomized, open label, parallel group, active controlled.
Dose / regimen: Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20
Primary Endpoint: Antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan versus lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of follow-up. Description % of change in albuminuria from baseline at 20 weeks.
Secondary Endpoint : To investigate the effect of 5 months treatment with valsartan,lisinopril and valsartan versus lisinopril in GFR (Cl creatinine), also to investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus lisinopril on blood pressure and the effect on left ventricular mass index using electrocardiogram and Cornell-Sokolow method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female outpatients aged 40-75 years,
- Chronic nephropathy, as defined by a serum creatinine concentration of > 1.3 mg/dL or calculated glomerular filtration rate of > 30 mL/min/1.73 m2.
- Persistent albuminuria, as defined by urinary albumin excretion exceeding 20 mg/ 24 h but not > 1000 mg/ 24h. (for a minimum of three months).
- Hypertensive patients not adequately controlled with or without treatment (controlled: <130/80 mmHg).
- Written informed consent to participate in the study prior to any study procedures.
Key exclusion criteria (10 listed)
- Immediate need for renal replacement therapy.
- Treatment resistant oedema or nephrotic syndrome.
- Need for treatment with corticosteroids, non-steroidal antiinflammatory drugs, or immunosuppressive drugs.
- Albuminuria greater than 1000mg /24h and or less than 20mg/24h.
- Total cholesterol < 135mg/dl or not need for statins treatment.
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, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ | Drug | – |
Primary outcome
Change from baseline in urine albumin excretion rate from collected urine samples, after 16 and 20 weeks
5 secondary outcomes
Blood pressure less than 130/80 mmHg after 16 and 20 weeks of treatment
Change from baseline 48-hour ambulatory blood pressure, and blood pressure less than 130/80 mmHg after 16 and 20 weeks of treatment
Blood pressure less than 130/80 mmHg at night, measured by 48-hour ambulatory blood pressure monitoring, after 16 and 20 weeks of treatment
Change from baseline in size of left heart ventricle by electrocardiogram (ECG) after 20 weeks
Change from baseline in kidney function after 16 and 20 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 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.
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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, VALSARTAN PLUS HCTZ, LISINOPRIL, LISINOPRIL PLUS HCTZ in people with Hypertension and Early Diabetic Nephropathy, run by Novartis 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 5 inclusion and 10 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 8 Nov 2011. 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 from collected urine samples, after 16 and 20 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 NCT00171600, 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 8 Nov 2011.