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

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

Study Overview

• Status: Unknown
• Conditions: Hypertension; Type 2 Diabetes
• Intervention / Treatment: Drug: Ramipril; Drug: Experimental

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Roberto Fogari, MD; Phone Number: +39 0382 526217; Email: r.fogari@unipv.it

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy, 27100
      • Recruiting
      • University of Pavia
      • Contact: Amedeo Mugellini, MD; Phone Number: +39 0382 526217; Email: amedeo.mugellini@unipv.it
      • Principal Investigator: Amedeo Mugellini, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Average of 24 hours by ABPM, systolic and diastolic blood pressure	3 months
Average daytime, systolic and diastolic blood pressure	3 months
Average night, systolic and diastolic blood pressure	3 months

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Study Director: Roberto Fogari, MD, University of Pavia

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): March 1, 2010
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: December 23, 2009
• First Submitted That Met QC Criteria: December 23, 2009
• First Posted (Estimate): December 24, 2009

Study Record Updates

• Last Update Posted (Estimate): December 24, 2009
• Last Update Submitted That Met QC Criteria: December 23, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Hypertension; type 2 diabetes; microalbuminuria; aliskiren; ramipril; 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: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypertension; Diabetes Mellitus, Type 2; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Ramipril
• Other Study ID Numbers: UNIPV002DIM2009; 2009-016481-83 (Registry Identifier: 2009-016481-83)