Management of Albuminuria in Hypertensive Diabetics | NCT01907958

Studies
Management of Albuminuria in Hypertensive Diabetics

NCT01907958

Sponsor

Medpharmgene, Inc.

Status

Unknown status

Last Update Posted

Jul 25, 2013Estimated

Enrollment

280Estimated

Phase

Not provided

Conditions

Microalbuminuria
Hypertension
Type 2 Diabetes

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Jun 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Jul 18, 2013

First Submission Date that Met QC Criteria

Jul 24, 2013

First Posted Date

Jul 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2013

Last Update Posted Date

Jul 25, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

280Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

18 years and older Uncontrolled blood pressure Type 2 diabetes

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marie-Renée GUERTIN, project manager	Contact	514 249 4209	222	m-r.guertin@medpharmgene.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medpharmgene	Recruiting	Montreal	Quebec	H1Y 3L1	Canada

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided