Aliskiren Versus Ramipril on Antiproteinuric Effect in Hy... | NCT01038895

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

NCT01038895

Sponsor

University of Pavia

Status

Unknown status

Last Update Posted

Dec 24, 2009Estimated

Enrollment

120Estimated

Phase

Phase 4

Conditions

Hypertension
Type 2 Diabetes

Interventions

Ramipril
Experimental

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-016481-83	Registry Identifier	2009-016481-83

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Dec 23, 2009

First Submission Date that Met QC Criteria

Dec 23, 2009

First Posted Date

Dec 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2009

Last Update Posted Date

Dec 24, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Conditions Module

Conditions

Hypertension
Type 2 Diabetes

Keywords

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ramipril	Active Comparator	10 mg/daily	Drug: Ramipril
Aliskiren	Experimental	300 mg/ daily	Drug: Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ramipril	Drug	tablet; 10 mg; od; 3 months	Ramipril
Experimental

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roberto Fogari, MD	Contact	+39 0382 526217		r.fogari@unipv.it

Overall Officials

Name	Affiliation	Role
Roberto Fogari, MD	University of Pavia	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pavia	Recruiting	Pavia	PV	27100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017257	Ramipril

Ancestor Terms

ID	Term
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided