NCT00409851

Brief Summary

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2201.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,293

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Apr 2003

Typical duration for phase_3 hypertension

Geographic Reach
2 countries

2 active sites

Status
completed

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

April 1, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2006

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

1.9 years

First QC Date

December 7, 2006

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

HYPERTENSION, VALSARTAN, AMLODIPINE,SAFETY

Outcome Measures

Primary Outcomes (1)

  • Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough.

Secondary Outcomes (3)

  • 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

  • Sitting and standing pulse

Interventions

valsartan+amlodipineDRUG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2201 CORE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Unknown Facility

Sites in Germany, Germany

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine, Valsartan Drug Combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ValsartanTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmlodipineDihydropyridinesPyridinesValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDrug CombinationsPharmaceutical Preparations

Study Officials

  • Novartis pharmaceuticals

    Sponsor GmbH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 11, 2006

Study Start

April 1, 2003

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

US(1)DE(1)