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

December 23, 2009
December 23, 2009
November 2009
March 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria
Not Provided

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Type 2 Diabetes
  • Drug: Ramipril
    tablet; 10 mg; od; 3 months
  • Drug: Experimental
    tablet; 300 mg; od; 3 months
  • Active Comparator: Ramipril
    10 mg/daily
    Intervention: Drug: Ramipril
  • Experimental: Aliskiren
    300 mg/ daily
    Intervention: Drug: Experimental
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2011
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Roberto Fogari, MD +39 0382 526217 r.fogari@unipv.it
Italy
 
NCT01038895
UNIPV002DIM2009, 2009-016481-83
No
University of Pavia
University of Pavia
Not Provided
Study Director: Roberto Fogari, MD University of Pavia
University of Pavia
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP