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

Hypertension Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01038895
• Other study ID #: UNIPV002DIM2009
• Secondary ID: 2009-016481-83
• Status: Recruiting
• Phase: Phase 4
• First received: December 23, 2009
• Last updated: December 23, 2009
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: September 2009
• Source: University of Pavia
• Contact: Roberto Fogari, MD
• Phone: +39 0382 526217
• Email: r.fogari[@]unipv.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes

Intervention

Drug:
• Ramipril
tablet; 10 mg; od; 3 months
• Experimental
tablet; 300 mg; od; 3 months

Locations

Country	Name	City	State
Italy	University of Pavia	Pavia	PV

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Average of 24 hours by ABPM, systolic and diastolic blood pressure		3 months	Yes
Secondary	Average daytime, systolic and diastolic blood pressure		3 months	Yes
Secondary	Average night, systolic and diastolic blood pressure		3 months	Yes