NCT00615108

Brief Summary

The purpose of this observational study is to survey the safety and effectiveness of the product under the real condition of usual practice in Taiwanese hypertensive patients. During the 8-week observation, the safety profiles and the clinical evaluation in between doses through blood pressure (BP) measurement for overall effectiveness of telmisartan therapy will be concluded.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
3,148

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

17 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

December 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 26, 2010

Completed
Last Updated

April 7, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

January 31, 2008

Results QC Date

December 16, 2009

Last Update Submit

February 28, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients Achieving Blood Pressure (BP) Control

    BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP\< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks.

    01-Dec-2006 to 31-Dec-2008

Secondary Outcomes (3)

  • Percentage of Patients Achieving BP Response

    01-Dec-2006 to 31-Dec-2008

  • Overall Assessment by Patients

    01-Dec-2006 to 31-Dec-2008

  • Overall Assessment by Attending Physicians

    01-Dec-2006 to 31-Dec-2008

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hypertension patients

You may qualify if:

  • \. Male or female. 2. Aged 20 to 80 years old. 3. Patients meet one of following two criteria:
  • Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic blood pressure (BP) \> 140 mmHg but \< 180 mmHg, and/or diastolic BP \> 90 mmHg but \< 110 mmHg).
  • Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication.

You may not qualify if:

  • Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert).
  • Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets.
  • Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Boehringer Ingelheim Investigator Site

Changhua, Taiwan

Location

Boehringer Ingelheim Investigator Site 1

Chiayi City, Taiwan

Location

Boehringer Ingelheim Investigator Site 2

Chiayi City, Taiwan

Location

Boehringer Ingelheim Investigator Site

Keelung, Taiwan

Location

Boehringer Ingelheim Investigator Site

Ksohsiung, Taiwan

Location

Boehringer Ingelheim Investigator Site

Miaoli, Taiwan

Location

Boehringer Ingelheim Investigator Site 1

Taichung, Taiwan

Location

Boehringer Ingelheim Investigator Site 2

Taichung, Taiwan

Location

Boehringer Ingelheim Investigator Site 1

Tainan, Taiwan

Location

Boehringer Ingelheim Investigator Site 2

Tainan, Taiwan

Location

Boehringer Ingelheim Investigator Site 1

Taipei, Taiwan

Location

Boehringer Ingelheim Investigator Site 2

Taipei, Taiwan

Location

Boehringer Ingelheim Investigator Site 3

Taipei, Taiwan

Location

Boehringer Ingelheim Investigator Site 4

Taipei, Taiwan

Location

Boehringer Ingelheim Investigator Site 5

Taipei, Taiwan

Location

Boehringer Ingelheim Investigator Site 6

Taipei, Taiwan

Location

Boehringer Ingelheim Investigator Site 7

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 14, 2008

Study Start

December 1, 2006

Primary Completion

December 1, 2008

Last Updated

April 7, 2014

Results First Posted

January 26, 2010

Record last verified: 2014-02

Locations

TW(17)