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

Tracking Information

First Received Date ^ICMJE

October 24, 2007

Last Updated Date

June 13, 2008

Start Date ^ICMJE

June 2007

Estimated Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Albumin Creatinine Ratio (ACR) from baseline over a period of 24 weeks. [ Time Frame: Week 24 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00550095 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percent reduction of (BP) at 24 weeks compared to baseline level. Percent of patients whose BP is controlled at 24 weeks (< 130/80) [ Time Frame: Week 24 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Microalbuminuria
Proteinuria

Intervention ^ICMJE

Drug: valsartan

Study Arms / Comparison Groups

Experimental: valsartan

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

700

Estimated Completion Date

June 2008

Estimated Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 β 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)

Gender

Both

Ages

35 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Egypt

Administrative Information

NCT ID ^ICMJE

NCT00550095

Responsible Party

Study ID Numbers ^ICMJE

CVAL489AEG03

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis Pharmaceuticals

Sponsor GmbH

Information Provided By

Novartis

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP