Effects of Aliskiren/Amlodipine Versus Amlodipine Monothe... | NCT01048047

Studies
Effects of Aliskiren/Amlodipine Versus Amlodipine Monotherapy on Ankle-foot Volume in Hypertensive Patients

NCT01048047

Sponsor

University of Pavia

Status

Unknown status

Last Update Posted

Jan 13, 2010Estimated

Enrollment

88Estimated

Phase

Phase 4

Conditions

Hypertension

Interventions

aliskiren/amlodipine

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
EudraCT 2009	Registry Identifier	EudraCT 2009-016479-30

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Dec 2009Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Jan 12, 2010

First Submission Date that Met QC Criteria

Jan 12, 2010

First Posted Date

Jan 13, 2010Estimated

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

Jan 12, 2010

Last Update Posted Date

Jan 13, 2010Estimated

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

Comparison between the effect of aliskiren/amlodipine combination with amlodipine monotherapy on ankle-foot volume in hypertensive patients. It will be enrolled male or female outpatients, aged 18-65 years.

Detailed Description

Not provided

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

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aliskiren/amlodipine	Experimental	aliskiren, 300 mg/amlodipine 10 mg	Drug: aliskiren/amlodipine
amlodipine	Active Comparator	amlodipine 10 mg	Drug: aliskiren/amlodipine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aliskiren/amlodipine	Drug	aliskiren 300 mg /amlodipine 10 mg	aliskiren/amlodipine amlodipine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure, heart rate, ankle-foot volume		At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure and heart rate in sitting and standing position		At baseline, at the end of the wash-out period, after 2, 4, and 8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diastolic blood pressure > 95 mmHg and < 110 mmHg
systolic blood pressure > 140 mmHg and < 180 mmHg
no amlodipine therapy for the previous 6 months

Exclusion Criteria:

diastolic blood pressure > 110 mmHg and or
systolic blood pressure > 180 mmHg
secondary hypertension
heart failure
diabetes mellitus
liver or kidney diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roberto Fogari, MD	University of Pavia	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D008224	Lymphoma, Follicular

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C446481	aliskiren
D017311	Amlodipine

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided