NCT00904215

Brief Summary

An observational study to investigate the efficacy, safety, tolerability and the effect on quality of life of Telmisartan (Micardis) and Telmisartan with HCTZ (Micardis Plus) in patients with hypertension

Trial Health

80
On Track

Trial Health Score

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

Enrollment
1,095

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

11 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

February 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 31, 2009

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

2.2 years

First QC Date

May 18, 2009

Results QC Date

May 22, 2009

Last Update Submit

April 3, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

  • Change in SBP (Systolic Blood Pressure)

    The change of the mean SBP

    between baseline (visit 1) and after 12 weeks of treatment (visit 3)

  • Change in DBP (Diastolic Blood Pressure)

    The change of the mean DBP

    between baseline (visit 1) and after 12 weeks of treatment (visit 3)

  • Change in WHO-QOL (WHO-Quality Of Life)

    World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed. Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life)

    between baseline (visit 1) and after 12 weeks of treatment (visit 3)

Secondary Outcomes (1)

  • Change in VAS (Visual Analog Scale)

    between baseline (visit 1) and after 12 weeks of treatment (visit 3)

Interventions

telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from clinics and hospitals in Korea

You may qualify if:

  • Ability to provide written/verbal informed consent in accordance with GCP (Good Clinical Practice) and local legislation
  • Patients aged 18 \~ under 80
  • Hypertension as described below:
  • Newly diagnosed patients with hypertension
  • Patients with current antihypertensive therapy

You may not qualify if:

  • Female subjects who are breastfeeding, pregnant or who plan to be pregnant during the study
  • Known or suspected secondary hypertension(e.g. pheochromocytoma)
  • Patients who have been treated with telmisartan prior to the acquisition of informed consent (including verbal informed consent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Boehringer ingelheim Investigational Site 1

Daegu, South Korea

Location

Boehringer ingelheim Investigational Site 4

Daegu, South Korea

Location

Boehringer ingelheim Investigational Site 7

Daegu, South Korea

Location

Boehringer ingelheim Investigational Site 9

Daejeon, South Korea

Location

Boehringer ingelheim Investigational Site 10

Koyang, South Korea

Location

Boehringer ingelheim Investigational Site 11

Kwangju, South Korea

Location

Boehringer ingelheim Investigational Site 3

Kwangju, South Korea

Location

Boehringer ingelheim Investigational Site 5

Pusan, South Korea

Location

Boehringer ingelheim Investigational Site 2

Seoul, South Korea

Location

Boehringer ingelheim Investigational Site 6

Suwon, South Korea

Location

Boehringer ingelheim Investigational Site 8

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

TelmisartanHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazides

Results Point of Contact

Title
Boehringer Ingelheim Pharmaceuticals
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
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 19, 2009

Study Start

February 1, 2005

Primary Completion

May 1, 2007

Last Updated

April 21, 2014

Results First Posted

August 31, 2009

Record last verified: 2014-04

Locations

KR(11)