Recruiting

Albuminuria Management

Sponsor:

Medpharmgene, Inc.

Code:

NCT01907958

Conditions

Microalbuminuria

Hypertension

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Microalbuminuria

Hypertension

Type 2 Diabetes

Study ID

NCT01907958

Start date

Apr, 2013

Status verified date

Jul, 2013

Completion date

Jun, 2014

Anticipated

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

280 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Stabilisation or improvement of urine albumin excretion status by at least one stage [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Marie-Renée GUERTIN, project manager

514 249 4209m-r.guertin@medpharmgene.ca

Locations

Medpharmgene

Recruiting

Montreal, Quebec, Canada, H1Y 3L1

Contacts

Marie-Renée Guertin, Project manager

514 249 4209m-r.guertin@medpharmgene.ca

Principal Investigator:

Pavel Hamet

More Information

Sponsor

Medpharmgene, Inc.

Last update posted

Jul 25, 2013

Last verified

Jul, 2013

Keywords

  • Microalbuminuria
  • Hypertensive
  • Diabetics
  • urine albumin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medpharmgene, Inc. on 2013-07-25.