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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Pavia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pavia
ClinicalTrials.gov Identifier:
NCT01038895
First received: December 23, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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:

  1. Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks at various visits
  2. 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

Condition Intervention Phase
Hypertension
Type 2 Diabetes
 Drug: Ramipril
Drug: Experimental
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pavia:

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. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Average of 24 hours by ABPM, systolic and diastolic blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Average daytime, systolic and diastolic blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Average night, systolic and diastolic blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: November 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ramipril
10 mg/daily
 Drug: Ramipril
tablet; 10 mg; od; 3 months
Experimental: Aliskiren
300 mg/ daily
 Drug: Experimental
tablet; 300 mg; od; 3 months

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038895

Contacts
Contact: Roberto Fogari, MD +39 0382 526217 r.fogari@unipv.it

Locations
Italy
University of Pavia Recruiting
Pavia, PV, Italy, 27100
Contact: Amedeo Mugellini, MD     +39 0382 526217     amedeo.mugellini@unipv.it    
Principal Investigator: Amedeo Mugellini, MD            
Sponsors and Collaborators
University of Pavia
Investigators
Study Director: Roberto Fogari, MD University of Pavia
  More Information

No publications provided

Responsible Party: University of Pavia
ClinicalTrials.gov Identifier: NCT01038895     History of Changes
Other Study ID Numbers: UNIPV002DIM2009, 2009-016481-83
Study First Received: December 23, 2009
Last Updated: December 23, 2009
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Pavia:
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)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Ramipril
 Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013