One Year Study to Evaluate the Safety of the Combination... | NCT00409851

Studies
One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension

NCT00409851

Sponsor

Novartis

Status

Completed

Last Update Posted

Nov 8, 2011Estimated

Enrollment

1,293Actual

Phase

Phase 3

Conditions

Hypertension

Interventions

valsartan+amlodipine

Countries

United States
Germany

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

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Mar 2005Actual

Completion Date

Mar 2005Actual

First Submitted Date

Dec 7, 2006

First Submission Date that Met QC Criteria

Dec 7, 2006

First Posted Date

Dec 11, 2006Estimated

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

Nov 7, 2011

Last Update Posted Date

Nov 8, 2011Estimated

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,293Actual

Name	Type	Description	Arm Group Labels	Other Names
valsartan+amlodipine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough.

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough
Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

SUCCESSFUL COMPLETION OF VAA489A2201 CORE TRIAL
VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg

Exclusion Criteria:

PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2201 CORE
Other protocol-defined exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis pharmaceuticals	Sponsor GmbH	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Pharmaceuticals		East Hanover	New Jersey	07936	United States

Label	URL
NOVARTIS PATIENT RECRUITMENT WEBSITE	View source

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068838	Amlodipine, Valsartan Drug Combination

Ancestor Terms

ID	Term
D000068756	Valsartan
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided