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Clinical Trials/NCT00550095
NCT00550095
Completed
Phase 4

A 24 Week, Multi-centre, Open Label, Non Controlled Study to Assess the Efficacy of Valsartan in Reducing Albuminuria/Proteinuria in Hypertensive Patients With Type 2 Diabetes Mellitus

Novartis1 site in 1 country509 target enrollmentJune 2007
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ConditionsMicroalbuminuriaProteinuria
Interventionsvalsartan
Drugsvalsartan

Overview

Phase
Phase 4
Intervention
valsartan
Conditions
Microalbuminuria
Sponsor
Novartis
Enrollment
509
Locations
1
Primary Endpoint
Change in Albumin Creatinine Ratio (ACR) from baseline over a period of 24 weeks.
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This study is designed to assess the efficacy of the different dosage forms of Valsartan[80, 160, and 320 mg] in reducing microalbuminuria/proteinuria in hypertensive patients with type 2 diabetes.

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
November 2009
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Novartis
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Males or females aged 35 to
  • •Type 2 diabetes mellitus (DM) patients coupled with hypertension \[sitting systolic blood pressure (SSBP) 140-179 mm Hg and/or SDBP 90-109 mm Hg\].
  • •Urinary albumin creatinine Ratio (UACR)) indicating microalbuminuria/proteinuria \[30-1000 mg/g or 2.5-25 mg/mmol\]
  • •Body mass index (BMI) \<40 kg/m2
  • •Patients who will sign an informed consent.
  • •Exclusion Criteria
  • •Type 1 DM
  • •All causes of secondary diabetes mellitus
  • •Women of childbearing potential who refuse to use contraception.
  • •Pregnant or lactating females.

Exclusion Criteria

  • Not provided

Arms & Interventions

1

valsartan

Intervention: valsartan

Outcomes

Primary Outcomes

Change in Albumin Creatinine Ratio (ACR) from baseline over a period of 24 weeks.

Time Frame: Week 24

Secondary Outcomes

  • Percent reduction of (BP) at 24 weeks compared to baseline level. Percent of patients whose BP is controlled at 24 weeks (< 130/80)(Week 24)

Study Sites (1)

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