NCT01038895

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. 1.Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks at various visits
  2. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 24, 2009

Status Verified

September 1, 2009

Enrollment Period

4 months

First QC Date

December 23, 2009

Last Update Submit

December 23, 2009

Conditions

HypertensionType 2 Diabetes

Keywords

Hypertensiontype 2 diabetesaliskirenramiprilmicroalbuminuriablood pressure> 130/80 <180/105 mmHg at the end of the wash-outtype 2 diabetes mellitus well controlled by medication and / orcompliance with diet (HbA1c <7%)Microalbuminuria in the upper range of normal (> 200 <300 mg/24 h)

Outcome Measures

Primary Outcomes (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.

    3 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

Ramipril

ACTIVE COMPARATOR

10 mg/daily

Drug: Ramipril

Aliskiren

EXPERIMENTAL

300 mg/ daily

Drug: Experimental

Interventions

RamiprilDRUG

tablet; 10 mg; od; 3 months

Ramipril
ExperimentalDRUG

tablet; 300 mg; od; 3 months

Aliskiren

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pavia

Pavia, PV, 27100, Italy

RECRUITING

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Roberto Fogari, MD

    University of Pavia

    STUDY DIRECTOR

Central Study Contacts

Roberto Fogari, MD

CONTACT

+39 0382 526217r.fogari@unipv.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2009

First Posted

December 24, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2010

Study Completion

June 1, 2011

Last Updated

December 24, 2009

Record last verified: 2009-09

Locations

IT(1)