NCT00170976

Brief Summary

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
403

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Apr 2004

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, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

September 10, 2005

Last Update Submit

October 11, 2023

Conditions

HYPERTENSION

Keywords

HYPERTENSION, VALSARTAN, AMLODIPINE< SAFETY

Outcome Measures

Primary Outcomes (1)

  • Adverse events and serious adverse events at each study visit for 6 or 12 months

Secondary Outcomes (5)

  • Change from baseline in diastolic blood pressure from baseline after 6 or 12 months

  • Change from baseline in systolic blood pressure from baseline after 6 or 12 months

  • Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months

  • Change from baseline in sitting and standing pulse after 6 or 12 months

  • Hematology and blood chemistry after 6 or 12 months

Interventions

valsartan + amlodipineDRUG

Eligibility Criteria

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

You may qualify if:

  • SUCCESSFUL COMPLETION OF VAA489A2307 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 VAA489A2307 CORE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sites in germany

Multiple Locations, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

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

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

April 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations

CH(1)DE(1)