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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:

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:

  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 or disease Intervention/treatment Phase
Hypertension Type 2 Diabetes Drug: Ramipril Drug: Experimental Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. Average of 24 hours by ABPM, systolic and diastolic blood pressure [ Time Frame: 3 months ]
  2. Average daytime, systolic and diastolic blood pressure [ Time Frame: 3 months ]
  3. Average night, systolic and diastolic blood pressure [ Time Frame: 3 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Pavia
ClinicalTrials.gov Identifier: NCT01038895     History of Changes
Other Study ID Numbers: UNIPV002DIM2009
2009-016481-83 ( Registry Identifier: 2009-016481-83 )
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: September 2009

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:
Hypertension
Diabetes Mellitus, Type 2
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents