HypertensionNCT00613314

Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

An observational study of Hypertension and Metabolic Syndrome X, run by Boehringer Ingelheim at 122 sites in Philippines.

Completed

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

Official record

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Trial summary

To determine the efficacy and safety of telmisartan-based treatment among patients with metabolic syndrome in actual setting in Philippines. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Hypertension, Metabolic Syndrome X
How many people: 15,268 participants
Where: 122 sitesPhilippines
Study dates: Jun 2007to Apr 2008
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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Primary care clinic

Who may be able to join

Age > 45 years
Increased waist circumference (>88.9cm [>35in] men, >78.7cm [>31in] for women)
Elevated triglycerides (>150mg/dl)
Low HDL cholesterol (<40mg/dl in men, <50mg/dl in women)
Hypertension (>130/>85mmHG)
Impaired fasting glucose (>110mg/dl) (8)
Hypertensive patient assessed to benefit from telmisartan based treatment

Who cannot join

Hypersensitivity to telmisartan, hydrochlorothiazide (HCTZ) and its excipients
<3 months myocardial infarction (MI), stroke or severe heart failure

Trial locations and contacts

122 sites in 1 country.

City, postcode or hospital

122 sites in 1 country

Philippines122 sites

Boehringer Ingelheim Investigational Site
Alaminos City, Pangasinan
Boehringer Ingelheim Investigational Site
Angeles City
Boehringer Ingelheim Investigational Site
Angeles City, Pampanga
Boehringer Ingelheim Investigational Site
Antipolo City, Rizal
Boehringer Ingelheim Investigational Site
Atabay, San Jose
Boehringer Ingelheim Investigational Site
Bacoor, Cavite
Boehringer Ingelheim Investigational Site
Baguio City, Benguet
Boehringer Ingelheim Investigational Site
Balanga City, Bataan
Boehringer Ingelheim Investigational Site
Baliuag, Balacan
Boehringer Ingelheim Investigational Site
Baliuag, Bulacan
Boehringer Ingelheim Investigational Site
Bangued, Abra
Boehringer Ingelheim Investigational Site
Batac, Ilocos Norte
Boehringer Ingelheim Investigational Site
Batangas City, Batangas
Boehringer Ingelheim Investigational Site
Batangas City. Batangas
Boehringer Ingelheim Investigational Site
Bauan Batangas
Boehringer Ingelheim Investigational Site
Bautista, Pangasinan
Boehringer Ingelheim Investigational Site
Binan, Laguna
Boehringer Ingelheim Investigational Site
Bocaue, Bulacan
Boehringer Ingelheim Investigational Site
Butuan
Boehringer Ingelheim Investigational Site
Butuan City, Agusan Del Norte
Boehringer Ingelheim Investigational Site
Cabanatuan City, Nueva Ecija
Boehringer Ingelheim Investigational Site
Cagayan de Oro City, Misamis
Boehringer Ingelheim Investigational Site
Cagayan de Oro City, Misamis Oriental
Boehringer Ingelheim Investigational Site
Cagayan de Oro, Misamis Oriental
Boehringer Ingelheim Investigational Site
Cainta, Rizal
Boehringer Ingelheim Investigational Site
Calamba CIty, Laguna
Boehringer Ingelheim Investigational Site
Calamba, Misamis Occidental
Boehringer Ingelheim Investigational Site
Calamban City, Laguna
Boehringer Ingelheim Investigational Site
Caloocan
Boehringer Ingelheim Investigational Site
Camiling, Laguna
Boehringer Ingelheim Investigational Site
Cando City, Ilocos Sur
Boehringer Ingelheim Investigational Site
Cauayan City, Isabela
Boehringer Ingelheim Investigational Site
Cavite City, Cavite
Boehringer Ingelheim Investigational Site
Cebu City, Cebu
Boehringer Ingelheim Investigational Site
City of Muntinlupa
Boehringer Ingelheim Investigational Site
Cruz, Manila
Boehringer Ingelheim Investigational Site
Dagupan City, Pangasinan
Boehringer Ingelheim Investigational Site
Dasmarinas, Cavite
Boehringer Ingelheim Investigational Site
De Vera, Santiago City, Isabela
Boehringer Ingelheim Investigational Site
Digolog City, Zamboanga Del Norte
Boehringer Ingelheim Investigational Site
Dinalupihan, Bataan
Boehringer Ingelheim Investigational Site
Dipolog City, Zamboange Del Norte
Boehringer Ingelheim Investigational Site
Ermita, Manila
Boehringer Ingelheim Investigational Site
Espana, Manila
Boehringer Ingelheim Investigational Site
F Cayco Sampaloc, Manila
Boehringer Ingelheim Investigational Site
Gapan City, Nueva Ecija
Boehringer Ingelheim Investigational Site
Gingoog City, Misamis Oriental
Boehringer Ingelheim Investigational Site
Greenhills, San Juan
Boehringer Ingelheim Investigational Site
Guagua, Pampanga
Boehringer Ingelheim Investigational Site
Iba, Zambales
Boehringer Ingelheim Investigational Site
Ibalong, LegazpiCity, Albay
Boehringer Ingelheim Investigational Site
Igano, Molave, Zamboanga Del Sur
Boehringer Ingelheim Investigational Site
Ilgan City, Lanao Del Norte
Boehringer Ingelheim Investigational Site
Iligan City, Lanao Del Norte
Boehringer Ingelheim Investigational Site
Iloilo City, Iloilo
Boehringer Ingelheim Investigational Site
Imus, Cavite
Boehringer Ingelheim Investigational Site
Kalibo, Aklan
Boehringer Ingelheim Investigational Site
Kalookan City, Tala
Boehringer Ingelheim Investigational Site
Kaloonkan City
Boehringer Ingelheim Investigational Site
Laoag City, Ilocos Norte
Boehringer Ingelheim Investigational Site
Laog City, Ilocos Norte
Boehringer Ingelheim Investigational Site
Lapu-lapu City, Cebu
Boehringer Ingelheim Investigational Site
Las Pina City
Boehringer Ingelheim Investigational Site
Las Piñas
Boehringer Ingelheim Investigational Site
Legazpi City, Albay
Boehringer Ingelheim Investigational Site
Lemery, Batangas
Boehringer Ingelheim Investigational Site
Limay, Bataan
Boehringer Ingelheim Investigational Site
Lipa City, Batangas
Boehringer Ingelheim Investigational Site
Lucena City, Quezon
Boehringer Ingelheim Investigational Site
Makati City
Boehringer Ingelheim Investigational Site
Malate, Manila
Boehringer Ingelheim Investigational Site
Mandaluyong
Boehringer Ingelheim Investigational Site
Mandaluyong City, Edsa
Boehringer Ingelheim Investigational Site
Marikina City
Boehringer Ingelheim Investigational Site
Marilao, Bulacan
Boehringer Ingelheim Investigational Site
Masangkay Tondo, Manila
Boehringer Ingelheim Investigational Site
Meycauayan, Bulacan
Boehringer Ingelheim Investigational Site
Morayta Sampaloc, Manila
Boehringer Ingelheim Investigational Site
Munoz City, Nueva Ecija
Boehringer Ingelheim Investigational Site
Naga City, Camarines Sur
Boehringer Ingelheim Investigational Site
Naga City, Carmarines Sur
Boehringer Ingelheim Investigational Site
Olonggapo City, Zambales
Boehringer Ingelheim Investigational Site
Ormoc City, Leyte
Boehringer Ingelheim Investigational Site
Oroquita City, Misamis Occidental
Boehringer Ingelheim Investigational Site
Ozamis City, Misamis
Boehringer Ingelheim Investigational Site
Ozamis City, Misamis Occidental
Boehringer Ingelheim Investigational Site
Paranaque City
Boehringer Ingelheim Investigational Site
Pasay
Boehringer Ingelheim Investigational Site
Pasig
Boehringer Ingelheim Investigational Site
Pinamalaayan, Calapan City, Oriental Mindoro
Boehringer Ingelheim Investigational Site
Pulilan, Bulacan
Boehringer Ingelheim Investigational Site
Quezon City
Boehringer Ingelheim Investigational Site
Quezon City, Diliman
Boehringer Ingelheim Investigational Site
Roxas City, Capiz
Boehringer Ingelheim Investigational Site
Roxas, Isabela
Boehringer Ingelheim Investigational Site
Sampaloc, Manila
Boehringer Ingelheim Investigational Site
San Carlos City, Pangasinan
Boehringer Ingelheim Investigational Site
San Fernanado City, Pampanga
Boehringer Ingelheim Investigational Site
San Fernando City, La Union
Boehringer Ingelheim Investigational Site
San Fernando City, Pampanga
Boehringer Ingelheim Investigational Site
San Miguel, Manila
Boehringer Ingelheim Investigational Site
San Pablo City, Laguna
Boehringer Ingelheim Investigational Site
San Pedro, Laguna
Boehringer Ingelheim Investigational Site
Santa Cruz, Laguna
Boehringer Ingelheim Investigational Site
Santa Maria, Bulacan
Boehringer Ingelheim Investigational Site
Santa Maria, Bulaccan
Boehringer Ingelheim Investigational Site
Santiago City, Isabela
Boehringer Ingelheim Investigational Site
Sorsogon City, Sorsogon
Boehringer Ingelheim Investigational Site
Surigao City, Surigao Del Norte
Boehringer Ingelheim Investigational Site
Taal, Batangas
Boehringer Ingelheim Investigational Site
Tacloban City, Leyte
Boehringer Ingelheim Investigational Site
Taft Ave, Manila
Boehringer Ingelheim Investigational Site
Taft, Manila
Boehringer Ingelheim Investigational Site
Tagbilaran City, Bohol
Boehringer Ingelheim Investigational Site
Tanauan City, Batangas
Boehringer Ingelheim Investigational Site
Tarlac City, Tarlac
Boehringer Ingelheim Investigational Site
Tondo, Manila
Boehringer Ingelheim Investigational Site
Tuguegarao City, Cagayan
Boehringer Ingelheim Investigational Site
Urdaneta City, Pangasinan
Boehringer Ingelheim Investigational Site
Valenzuela
Boehringer Ingelheim Investigational Site
Vigan City, Ilocos Sur
Boehringer Ingelheim Investigational Site
Vigan City. Ilocos Sur

Other trials in Philippines

About this study

Official title: Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen (CENTER)

To determine the efficacy and safety of telmisartan-based treatment among patients with metabolic syndrome in actual setting in Philippines.

Conditions: Hypertension, Metabolic Syndrome X
Medical subject headings: Hypertension, Metabolic Syndrome

What is being measured

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

Response Rate at the End of 30 Day Period
Response rate of Blood Pressure assessed in the following categories:
- Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline
- Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline Sitting BP normalization < 130 mmHg and DBP < 85 mmHg
Measured: End of 30 day Period
Response Rate at the End of 60 Day Period
Response rate on Blood Pressure:
1. Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline.
2. Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline.
3. Sitting BP normalization < 130 mmHg and DBP < 85 mmHg
Measured: At the end of 60 day period
Change in Systolic Blood Pressure (SBP) From Baseline
Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)
Measured: Baseline and 60 days
Change in Diastolic Blood Pressure (DBP) From Baseline
Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)
Measured: Baseline and 60 days

Secondary outcomes (1)

Percentage of Patients With Presence of Metabolic Risk Factor
Presence of metabolic risk factor was identified by the existence of 3 out of the 5 risk factors namely:
a.) presence of diabetes mellitus; b) presence of dyslipidemia; c) presence of albuminuria; d) presence of ventricular hypertrophy; and e) presence of co-morbidities,
based on patients' Medical History
Measured: At the end of 60 day period

Timeline

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

Jun 2007Apr 2008

First posted13 Feb 2008 (estimated)
Study startJun 2007
Primary completionApr 2008

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
Observational model: Cohort
Time perspective: Prospective
Enrolment: 15,268 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00613314
Sponsor's protocol ID: 502.532
Status last verified: Apr 2014
First submitted: 31 Jan 2008
Last updated: 26 May 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?

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Study at a glance

From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen (CENTER)
ClinicalTrials.gov ID: NCT00613314
Acronym / sponsor ID: 502.532
Conditions: Hypertension, Metabolic Syndrome X
Study type: Observational
Recruitment status: Completed
Enrolment: 15,268 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Apr 2008 (actual)
First posted: 13 Feb 2008 (estimated)
Results: Posted 5 Mar 2010

Clinical summary

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

To determine the efficacy and safety of telmisartan-based treatment among patients with metabolic syndrome in actual setting in Philippines.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Primary care clinic

Key inclusion criteria (7 listed)

Age > 45 years
Increased waist circumference (>88.9cm [>35in] men, >78.7cm [>31in] for women)
Elevated triglycerides (>150mg/dl)
Low HDL cholesterol (<40mg/dl in men, <50mg/dl in women)
Hypertension (>130/>85mmHG)

Key exclusion criteria (2 listed)

Hypersensitivity to telmisartan, hydrochlorothiazide (HCTZ) and its excipients
<3 months myocardial infarction (MI), stroke or severe heart failure

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

Primary outcome

Response Rate at the End of 30 Day Period
Time frame: End of 30 day Period
Response rate of Blood Pressure assessed in the following categories: * Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline * Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline Sitting BP normalization < 130 mmHg and DBP < 85 mmHg
Response Rate at the End of 60 Day Period
Time frame: At the end of 60 day period
Response rate on Blood Pressure: 1. Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline. 2. Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline. 3. Sitting BP normalization < 130 mmHg and DBP < 85 mmHg
Change in Systolic Blood Pressure (SBP) From Baseline
Time frame: Baseline and 60 days
Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)
Change in Diastolic Blood Pressure (DBP) From Baseline
Time frame: Baseline and 60 days
Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)

1 secondary outcome

Percentage of Patients With Presence of Metabolic Risk Factor
Time frame: At the end of 60 day period

Results and safety

Results posted to the registry on 5 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telmisartan (Micardis)	15,268	15,113

Primary outcome: Response Rate at the End of 30 Day Period

Time frame: End of 30 day Period. Number. Unit: Percentage of patients

Measure	Telmisartan (Micardis) n = 14161
Sitting SBP response	41.4
Sitting DBP response	66.3
Sitting BP normalization	31.2

Population analysed: ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

Primary outcome: Response Rate at the End of 60 Day Period

Time frame: At the end of 60 day period. Number. Unit: Percentage of patients

Measure	Telmisartan (Micardis) n = 14161
Sitting SBP response	75.5
Sitting DBP response	88.1
Sitting BP normalization	69.1

Population analysed: ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

Primary outcome: Change in Systolic Blood Pressure (SBP) From Baseline

Time frame: Baseline and 60 days. Mean (Standard Deviation). Unit: mmHg

Measure	Telmisartan (Micardis) n = 14161
Value	30.2 (15.4)

Population analysed: ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

Primary outcome: Change in Diastolic Blood Pressure (DBP) From Baseline

Time frame: Baseline and 60 days. Mean (Standard Deviation). Unit: mmHg

Measure	Telmisartan (Micardis) n = 14161
Value	15.9 (10)

Population analysed: ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Upto 60 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telmisartan (Micardis)	5 of 15,268 (0%)	0 of 15,268 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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

122 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 and Metabolic Syndrome X, run by Boehringer Ingelheim at 122 sites in Philippines.

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 7 inclusion and 2 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 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in Philippines. 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 5 Mar 2010). 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?

Response Rate at the End of 30 Day Period (time frame: End of 30 day Period). The study lists 4 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 NCT00613314.

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 26 May 2014.