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

An observational study of Hypertension, run by Boehringer Ingelheim at 11 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hypertension
What is being tested?: telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)
How many people: 1,095 participants
Where: 11 sitesSouth Korea
Study dates: Feb 2005to May 2007
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients from clinics and hospitals in Korea

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

South Korea11 sites

Boehringer ingelheim Investigational Site 1
Daegu
Boehringer ingelheim Investigational Site 4
Daegu
Boehringer ingelheim Investigational Site 7
Daegu
Boehringer ingelheim Investigational Site 9
Daejeon
Boehringer ingelheim Investigational Site 10
Koyang
Boehringer ingelheim Investigational Site 11
Kwangju
Boehringer ingelheim Investigational Site 3
Kwangju
Boehringer ingelheim Investigational Site 5
Pusan
Boehringer ingelheim Investigational Site 2
Seoul
Boehringer ingelheim Investigational Site 6
Suwon
Boehringer ingelheim Investigational Site 8
Wŏnju

Other trials in South Korea

About this study

Official title: A Post Marketing 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

Conditions: Hypertension
Being tested: telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in SBP (Systolic Blood Pressure)
The change of the mean SBP
Measured: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
Change in DBP (Diastolic Blood Pressure)
The change of the mean DBP
Measured: 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)
Measured: between baseline (visit 1) and after 12 weeks of treatment (visit 3)

Secondary outcomes (1)

Change in VAS (Visual Analog Scale)
VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status)
Measured: between baseline (visit 1) and after 12 weeks of treatment (visit 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2005May 2007

First posted19 May 2009 (estimated)
Study startFeb 2005
Primary completionMay 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 1,095 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00904215
Sponsor's protocol ID: 502.487
Status last verified: Apr 2014
First submitted: 18 May 2009
Last updated: 21 Apr 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post Marketing 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
ClinicalTrials.gov ID: NCT00904215
Acronym / sponsor ID: 502.487
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 1,095 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2005
Primary completion: May 2007 (actual)
First posted: 19 May 2009 (estimated)
Results: Posted 31 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Time perspective: Prospective

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients from clinics and hospitals in Korea

Key inclusion criteria (5 listed)

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:

Key exclusion criteria (3 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)	Drug	–

Primary outcome

Change in SBP (Systolic Blood Pressure)
Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
The change of the mean SBP
Change in DBP (Diastolic Blood Pressure)
Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
The change of the mean DBP
Change in WHO-QOL (WHO-Quality Of Life)
Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
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)

1 secondary outcome

Change in VAS (Visual Analog Scale)
Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)

Results and safety

Results posted to the registry on 31 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Micardis/Micardis Plus	1,095	960

Primary outcome: Change in SBP (Systolic Blood Pressure)

Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3). Mean (Standard Deviation). Unit: mmHg

Measure	Micardis/Micardis Plus n = 958
Value	-18 (19)

Micardis/Micardis Plus: p <0.0001, Student Paired t-test

Population analysed: In clinical report form (CRF), some patients' SBP was not recorded.

Primary outcome: Change in DBP (Diastolic Blood Pressure)

Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3). Mean (Standard Deviation). Unit: mmHg

Measure	Micardis/Micardis Plus n = 958
Value	-10 (12)

Micardis/Micardis Plus: p <0.0001, Student Paired t-test

Primary outcome: Change in WHO-QOL (WHO-Quality Of Life)

Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3). Mean (Standard Deviation). Unit: Units on a scale

Measure	Micardis/Micardis Plus n = 956
Value	2.5 (7.9)

Micardis/Micardis Plus: p <0.0001, Student Paired t-test

1 secondary outcome is reported in the full results.

Adverse events

Time frame: After signing informed consent through the end of study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Micardis/Micardis Plus	8 of ?	0 of 1,095 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Boehringer Ingelheim at 11 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in SBP (Systolic Blood Pressure) (time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00904215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.