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Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria

Primary Purpose

Hypertension, Type 2 Diabetes

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ramipril
Experimental
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, type 2 diabetes, aliskiren, ramipril, microalbuminuria, blood pressure> 130/80 <180/105 mmHg at the end of the wash-out, type 2 diabetes mellitus well controlled by medication and / or, compliance with diet (HbA1c <7%), Microalbuminuria in the upper range of normal (> 200 <300 mg/24 h)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • blood pressure > 130/80 <180/105 mmHg at the end of the wash-out
  • type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c <7%)
  • microalbuminuria in the upper range of normal (> 200 <300 mg/24 h)

Exclusion Criteria:

  • Pregnancy, lactation or women of childbearing age
  • Sitting diastolic blood pressure e 105 mmHg or systolic pressure e 180 at the end of the period of wash-out
  • History of hypertensive encephalopathy or cerebrovascular accident within 6 months
  • Secondary hypertension
  • Heart Failure
  • Myocardial infarction within 6 months
  • Angina pectoris, clinically significant valvular disease or arrhythmia
  • Alteration indices of liver function or renal
  • Known hypersensitivity to ACE inhibitors
  • All other physiological or pathological condition in the opinion of the physician may affect the evaluation of the parameters under study

Sites / Locations

  • University of PaviaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ramipril

Aliskiren

Arm Description

10 mg/daily

300 mg/ daily

Outcomes

Primary Outcome Measures

Antiproteinuric effect as well as antihypertensive effect of aliskiren 300 mg / daily versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria.

Secondary Outcome Measures

Average of 24 hours by ABPM, systolic and diastolic blood pressure
Average daytime, systolic and diastolic blood pressure
Average night, systolic and diastolic blood pressure

Full Information

First Posted
December 23, 2009
Last Updated
December 23, 2009
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT01038895
Brief Title
Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pavia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to assess the extent and trend in time of antiproteinuric effect as well as that antihypertensive effect of aliskiren 300 mg / d versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria. The investigators will also evaluate: Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks at various visits Average daytime, as determined by ABPM, systolic and diastolic blood pressure checks at various visits 3. Average night, as determined by ABPM, systolic and diastolic blood pressure checks at various visits

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Type 2 Diabetes
Keywords
Hypertension, type 2 diabetes, aliskiren, ramipril, microalbuminuria, blood pressure> 130/80 <180/105 mmHg at the end of the wash-out, type 2 diabetes mellitus well controlled by medication and / or, compliance with diet (HbA1c <7%), Microalbuminuria in the upper range of normal (> 200 <300 mg/24 h)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ramipril
Arm Type
Active Comparator
Arm Description
10 mg/daily
Arm Title
Aliskiren
Arm Type
Experimental
Arm Description
300 mg/ daily
Intervention Type
Drug
Intervention Name(s)
Ramipril
Intervention Description
tablet; 10 mg; od; 3 months
Intervention Type
Drug
Intervention Name(s)
Experimental
Intervention Description
tablet; 300 mg; od; 3 months
Primary Outcome Measure Information:
Title
Antiproteinuric effect as well as antihypertensive effect of aliskiren 300 mg / daily versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Average of 24 hours by ABPM, systolic and diastolic blood pressure
Time Frame
3 months
Title
Average daytime, systolic and diastolic blood pressure
Time Frame
3 months
Title
Average night, systolic and diastolic blood pressure
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: blood pressure > 130/80 <180/105 mmHg at the end of the wash-out type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c <7%) microalbuminuria in the upper range of normal (> 200 <300 mg/24 h) Exclusion Criteria: Pregnancy, lactation or women of childbearing age Sitting diastolic blood pressure e 105 mmHg or systolic pressure e 180 at the end of the period of wash-out History of hypertensive encephalopathy or cerebrovascular accident within 6 months Secondary hypertension Heart Failure Myocardial infarction within 6 months Angina pectoris, clinically significant valvular disease or arrhythmia Alteration indices of liver function or renal Known hypersensitivity to ACE inhibitors All other physiological or pathological condition in the opinion of the physician may affect the evaluation of the parameters under study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Fogari, MD
Phone
+39 0382 526217
Email
r.fogari@unipv.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Fogari, MD
Organizational Affiliation
University of Pavia
Official's Role
Study Director
Facility Information:
Facility Name
University of Pavia
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amedeo Mugellini, MD
Phone
+39 0382 526217
Email
amedeo.mugellini@unipv.it
First Name & Middle Initial & Last Name & Degree
Amedeo Mugellini, MD

12. IPD Sharing Statement

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Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria

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