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

This study is ongoing, but not recruiting participants.

First Received: October 24, 2007 Last Updated: 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:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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:

MedlinePlus related topics: Diabetes

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
1: Experimental 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

Study ID Numbers:	CVAL489AEG03
Study First Received:	October 24, 2007
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00550095 History of Changes
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
Metabolic Diseases
Urination Disorders
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Urological Manifestations
Signs and Symptoms
Proteinuria
Urologic Diseases
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Valsartan

ClinicalTrials.gov processed this record on November 30, 2009