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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by Novartis. Recruitment status was Active, not recruiting

First Received on October 24, 2007. Last Updated on June 13, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00550095

Purpose

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.

Condition	Intervention	Phase
Microalbuminuria Proteinuria	Drug: valsartan	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	700
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 valsartan	Drug: valsartan

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550095

Locations

Egypt
Novartis Investigative Site ,
Cairo, Egypt

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

Sponsor GmbH

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00550095 History of Changes
Other Study ID Numbers:	CVAL489AEG03
Study First Received:	October 24, 2007
Last Updated:	June 13, 2008
Health Authority:	Egypt: Health Authorities

Keywords provided by Novartis:

Microalbuminuria/proteinuria
hypertensive patients with type 2 diabetes
Valsartan
microalbuminuria/proteinuria in hypertensive patients with type 2 diabetes

Additional relevant MeSH terms:

Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012