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

Primary Purpose

Microalbuminuria, Proteinuria

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
valsartan
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microalbuminuria focused on measuring Microalbuminuria/proteinuria, hypertensive patients with type 2 diabetes, Valsartan, microalbuminuria/proteinuria in hypertensive patients with type 2 diabetes

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Novartis Investigative Site ,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

valsartan

Outcomes

Primary Outcome Measures

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

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)

Full Information

First Posted
October 24, 2007
Last Updated
February 21, 2017
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00550095
Brief Title
To Assess the Effects of Valsartan on Albuminuria/Proteinuria in Hypertensive Patients With Type 2 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microalbuminuria, Proteinuria
Keywords
Microalbuminuria/proteinuria, hypertensive patients with type 2 diabetes, Valsartan, microalbuminuria/proteinuria in hypertensive patients with type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
509 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
valsartan
Intervention Type
Drug
Intervention Name(s)
valsartan
Primary Outcome Measure Information:
Title
Change in Albumin Creatinine Ratio (ACR) from baseline over a period of 24 weeks.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigative Site ,
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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