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

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ClinicalTrials.gov Identifier: NCT01038895
Recruitment Status : Unknown
Verified September 2009 by University of Pavia.
Recruitment status was:  Recruiting
First Posted : December 24, 2009
Last Update Posted : December 24, 2009
Sponsor:
Information provided by:
University of Pavia

Tracking Information
First Submitted Date  ICMJE December 23, 2009
First Posted Date  ICMJE December 24, 2009
Last Update Posted Date December 24, 2009
Study Start Date  ICMJE November 2009
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2009)
  • Average of 24 hours by ABPM, systolic and diastolic blood pressure [ Time Frame: 3 months ]
  • Average daytime, systolic and diastolic blood pressure [ Time Frame: 3 months ]
  • Average night, systolic and diastolic blood pressure [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria
Official Title  ICMJE Not Provided
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:

  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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Type 2 Diabetes
Intervention  ICMJE
  • Drug: Ramipril
    tablet; 10 mg; od; 3 months
  • Drug: Experimental
    tablet; 300 mg; od; 3 months
Study Arms  ICMJE
  • Active Comparator: Ramipril
    10 mg/daily
    Intervention: Drug: Ramipril
  • Experimental: Aliskiren
    300 mg/ daily
    Intervention: Drug: Experimental
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 23, 2009)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01038895
Other Study ID Numbers  ICMJE UNIPV002DIM2009
2009-016481-83 ( Registry Identifier: 2009-016481-83 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pavia
Study Sponsor  ICMJE University of Pavia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Roberto Fogari, MD University of Pavia
PRS Account University of Pavia
Verification Date September 2009

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