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OpenTrials
Completed

NCT Number: NCT00550095

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

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.

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Key information

Conditions

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

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site ,

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

valsartan

Drug

Primary outcomes

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

    Time frame: 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)

    Time frame: Week 24

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 26, 2007
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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