NCT00171444

Brief Summary

The purpose of the study is to determine whether a specific training of General Practitioners (Family Physicians) regarding the new official guidelines for the treatment of hypertension results in a higher control of high Blood pressure in their patient population.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4,445

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_4 hypertension

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

June 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

November 8, 2011

Status Verified

September 1, 2005

Enrollment Period

11 months

First QC Date

September 12, 2005

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

hypertension,valsartan+hydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

  • Blood pressure less than 140/90 mmHg in non-diabetic patients, or less than 130/80 mmHg in patients with diabetes or kidney disease, after 8 weeks

Secondary Outcomes (4)

  • Change from baseline systolic blood pressure after 8 weeks

  • Change from baseline diastolic blood pressure after 8 weeks

  • Diastolic blood pressure less than 90 mmHg or reduction in diastolic blood pressure greater than 10 mmHg

  • Systolic blood pressure less than 140 mmHg or reduction in diastolic blood pressure greater than 15 mmHg

Interventions

Medical educationBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Male or female patients \>18 years of age
  • Hypertension defined by MSDBP ≥ 90 and /or MSSBP ≥ 140 mmHg for untreated patients, patients on diet and exercise, patients on current anti-hypertensive monotherapy or bitherapy treatment who remain uncontrolled or patients experiencing unacceptable side-effects,

You may not qualify if:

  • Severe hypertension, secondary hypertension, type 1 diabetes mellitus
  • History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novatis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

June 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

November 8, 2011

Record last verified: 2005-09