Management of Albuminuria in Hypertensive Diabetics (CLINPRADIA)

July 24, 2013 updated by: Medpharmgene, Inc.

A Multicentre Study to Evaluate the Management of Microalbuminuria in Hypertensive Patients With Type 2 Diabetes: Improving Clinical Practice

Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin to usual practice on quality of care in hypertensive patients with Type 2 diabetes.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1Y 3L1
        • Recruiting
        • Medpharmgene
        • Contact:
        • Principal Investigator:
          • Pavel Hamet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

18 years and older Uncontrolled blood pressure Type 2 diabetes

Description

Inclusion Criteria:

  • Male or female 18 years and older and able to visit the study sites every 3 months
  • T2D patients with ongoing anti-diabetic therapy for at least 5 years
  • Uncontrolled hypertension according to 2012 CHEP recommendations for management of hypertension in diabetic patients ( i.e. BP> 130/80 mmHg)
  • Able and agreeing to provide informed consent.

Exclusion Criteria:

  • Type 1 diabetes patients
  • Ongoing therapy with perindopril,
  • Known hypersensitivity or allergies to ACEI or sulfonamide derivatives,
  • A history of angioedema related or not to previous treatment with ACEI,
  • Impaired renal function defined as serum creatinine levels > 177 µmol/L, eGFR <30 mL/min,
  • Hyperkalemia or hypokalemia,
  • Severe hepatic impairment,
  • Use of non-antiarrhythmic agents causing torsade de pointes,
  • Pregnant or lactating women, or who are planning to become pregnant,
  • Any conditions which may impact on participation according to treating physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stabilisation or improvement of urine albumin excretion status by at least one stage
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Microalbuminuria (or further stages of CKD) after 12 months
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Demographics, medical history and medication Diabetes and hypertension status Blood pressure measurements
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medpharmgene, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 24, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

July 25, 2013

Last Update Submitted That Met QC Criteria

July 24, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLINPRADIA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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