NCT00171574

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

September 12, 2005

Last Update Submit

February 22, 2017

Conditions

HypertensionDiabetic Nephropathy

Keywords

valsartanlisinoprilantiproteinuricdiabetic nephropathy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in urine protein excretion after 20 weeks

Secondary Outcomes (3)

  • Change from baseline in a laboratory measure of kidney function after 20 weeks

  • Change from baseline in systolic blood pressure after 20 weeks

  • Change from baseline in diastolic blood pressure after 20 weeks

Interventions

ValsartanDRUG
Valsartan plus HCTZDRUG
LisinoprilDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female outpatients aged 18-70 years,
  • 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.
  • Persistent proteinuria, as defined by urinary protein excretion exceeding 1g/24 h. (for a minimum of three months ).
  • Normotensive and hypertensive patients not adequately controlled with or without treatment (controlled: \<125/75 mmHg).
  • Written informed consent to participate in the study prior to any study procedures.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

Basel, Switzerland

Location

MeSH Terms

Conditions

HypertensionDiabetic Nephropathies

Interventions

ValsartanHydrochlorothiazideLisinopril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDipeptidesOligopeptidesPeptides

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

November 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

CH(1)