Clinical trial NCT00171574: Antiproteinuric Effect of Valsartan and Lisinopril
Official title: Antiproteinuric Effect of Valsartan, Lisinopril and Valsartan Plus Lisinopril in Non-diabetic and Diabetic Renal Disease: a Randomized, Double Blind, Parallel Group, Controlled Trial With 5 Months Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Diabetic Nephropathy
Keywords: valsartan
lisinopril
antiproteinuric
diabetic nephropathy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Title: Antiproteinuric effect of valsartan, lisinopril and valsartan versus lisinopril in non-diabetic and diabetic renal disease: a randomized (3:3:1), double blind, parallel group, controlled trial, 5 months follow-up.

Objective: To evaluate the antiproteinuric effect of high doses of valsartan vs combo treatment in no-diabetic and diabetic patients.

Hypothesis: Combo treatment reduces microalbuminuria, proteinuria and the albumin/creatinin ratio more than monotherapies.

Design: Multicentric, randomized, double blind, parallel group, active controlled.

Dose / regimen Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20


Eligibility criteria: Inclusion Criteria:

1. Male or female outpatients aged 18-70 years,
2. Chronic nephropathy, as defined by a serum creatinine concentration of \> 3 mg/dL or calculated glomerular filtration rate of \> 30 mL/min/1.73 m2.
3. Persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimum of three months ).
4. Normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: \<125/75 mmHg).
5. Written informed consent to participate in the study prior to any study procedures.

Exclusion Criteria

* Immediate need for renal replacement therapy.
* Treatment resistant oedema.
* Need for treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs.
* Proteinuria greater than 10g /24h and/or hypoalbuminaemia less than 28g/L.
* Renovascular hypertension
* 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 ümol/L

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in urine protein excretion after 20 weeks
Secondary outcomes:
measure: Change from baseline in a laboratory measure of kidney function after 20 weeks
measure: Change from baseline in systolic blood pressure after 20 weeks
measure: Change from baseline in diastolic blood pressure after 20 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: