NCT00351130

Brief Summary

Essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. It contributes to cardiovascular disease development, a major and well established risk factor. A patient non compliant to drug therapy is recognized as one of the primary reasons for inadequate blood pressure control.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_4 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

First Submitted

Initial submission to the registry

March 16, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

March 16, 2006

Last Update Submit

February 22, 2017

Conditions

Hypertension

Keywords

Hypertension,stage 1 hypertension,stage 2 hypertension,valsartan,amlodipine,

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 22 weeks

Secondary Outcomes (2)

  • Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 14 and 22 weeks

  • Adverse events after 22 weeks

Interventions

valsartanDRUG
amlodipineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MSSBP\> 140 mm Hg, and/or MSDBP\> 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at end of core study

You may not qualify if:

  • Premature discontinuation in the core study or failure to comply with the core study protocol
  • Any patient that the investigator decides should not participate in the extension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Investigative Centers, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

MeSH Terms

Conditions

Hypertension

Interventions

ValsartanAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDihydropyridinesPyridines

Study Officials

  • Novartis Pharmaceuticals

    Novatis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2006

First Posted

July 12, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

DE(1)CH(1)