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

NCT00550095 | Completed Phase 4

• 1 other identifier: CVAL489AEG03
• Study Type: interventional
• Target: 509
• Locations: 1 country
• Sites: 1

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.

Conditions

Microalbuminuria; Proteinuria

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Week 24

Secondary Outcomes (1)

• 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 Arms (1)

1

EXPERIMENTAL

valsartan

Drug: valsartan

Interventions

valsartan DRUG

1

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigative Site ,

Cairo, Egypt

Location

MeSH Terms

Conditions

Proteinuria

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Novartis Pharmaceuticals

  Sponsor GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 26, 2007
• Study Start: June 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

EG (1)