Perindopril vs Ramipril for Persistence in MAU Reduction Study
ENDURE
1 other identifier
interventional
23
1 country
1
Brief Summary
The investigators conducted a single center study controlled study involving 20 patients with Type 2 Diabetes and hypertension who were randomly assigned to receive ramipril 10mg or perindopril 8mg. The primary endpoint was difference in urine albumin-creatinine ratio at night time and during the day. Secondary endpoint was measurement of blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes
Started Apr 2010
Longer than P75 for phase_3 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 24, 2016
CompletedFirst Posted
Study publicly available on registry
April 6, 2016
CompletedApril 6, 2016
March 1, 2016
2.3 years
March 24, 2016
March 31, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Urine albumin:creatinine ratio day and night
spot urine samples
24 hours
24 Hour Ambulatory Blood Pressure Monitoring
24 hour, day, and night systolic and diastolic blood pressure
24 hours
Study Arms (2)
Ramipril
ACTIVE COMPARATORMaximal recommended dose of ramipril "Altace®" (10 mg/d) given as an active comparator for 12 week.
Perindopril
EXPERIMENTALPerindopril "Coversyl®" at maximal recommended dose (8 mg/d) as experimental therapy for 12 weeks.
Interventions
Comparison of two renin angiotensin aldosterone inhibitors
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes,
- stable therapy with an ACEi or ARB for 8 weeks prior to screening period
- blood pressure controlled to \< 130/80 mmHg
You may not qualify if:
- Pregnancy,
- dual therapy with ACEi and ARB 8 weeks prior to screening
- history of cough with ACEi
- hypersensitivity to either medication
- myocardial infarction within 12 weeks of screening
- congestive heart failure (NYHA Class IV)
- severe coronary artery disease
- severe liver disease
- renal artery stenosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- Serviercollaborator
Study Sites (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
March 24, 2016
First Posted
April 6, 2016
Study Start
April 1, 2010
Primary Completion
August 1, 2012
Study Completion
December 1, 2012
Last Updated
April 6, 2016
Record last verified: 2016-03