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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00550095

Enrollment

509

Registered

2007-10-26

Start date

2007-06-30

Completion date

2009-11-30

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microalbuminuria, Proteinuria

Keywords

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

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.

Interventions

DRUGvalsartan

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Change in Albumin Creatinine Ratio (ACR) from baseline over a period of 24 weeks.	Week 24

Secondary

Measure	Time frame
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026