To Assess the Effects of Valsartan on Albuminuria/Proteinuria in Hypertensive Patients With Type 2 Diabetes Mellitus

Proteinuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550095
• Other study ID #: CVAL489AEG03
• Status: Completed
• Phase: Phase 4
• First received: October 24, 2007
• Last updated: February 21, 2017
• Start date: June 2007
• Est. completion date: November 2009

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• Males or females aged 35 to 75.

• 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.

• Severe hypertension [SSBP> 180 mmHg, sitting diastolic blood pressure (SDBP) > 110 mmHg ]

• Patients who are on combo therapy to control BP

• Patients who are already on Valsartan.

• Hypersensitivity to Valsartan.

• Renal artery stenosis [ unilateral or bilateral]

• Patients taking ß blockers, (Angiotensin Converting Enzyme Inhibitor (ACEI) or spironolactone

• Heart Failure

• History of myocardial infarction, Percutaneous Transluminal Coronary Angioplasty(PTCA) or cerebrovascular accident within the preceding 3 months.

• Creatinine levels > 1.4 mg/dl [ 0.07mmol/l]. Liver enzymes > 2 times Upper Limit of the Normal Range(ULN). Diabetic keto-acidosis (DKA) within the last 6 months. Presence of diabetic neuropathy or retinopathy. Diabetic foot complications. Presence of infection at time of screening. Hyperkalemia (serum K+ > 5.5 mmol/L)

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Microalbuminuria
• Proteinuria

Intervention

Drug:
• valsartan

Locations

Country	Name	City	State
Egypt	Novartis Investigative Site ,	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Albumin Creatinine Ratio (ACR) from baseline over a period of 24 weeks.		Week 24
Secondary	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

External Links

•   Results for CVAL489AEG03 from the Novartis Clinical Trials website