Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen (CENTER)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00613314

Enrollment

15268

Registered

2008-02-13

Start date

2007-06-30

Completion date

Unknown

Last updated

2014-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Metabolic Syndrome X

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Response Rate at the End of 30 Day Period	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	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	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	Baseline and 60 days	Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)

Secondary

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

Countries

Philippines

Participant flow

Recruitment details

The protocol specified that the study will consist of 16,000 subjects. However, there are only 15, 268 case report forms (CRFs) submitted

Participants by arm

Arm	Count
Telmisartan (Micardis)	14,161
Total	14,161

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	5
Overall Study	Lost to Follow-up	46
Overall Study	Other reason not defined above	90
Overall Study	Protocol Violation	14

Baseline characteristics

Characteristic	Telmisartan (Micardis)
Age, Continuous	59 Years STANDARD_DEVIATION 9.9
Gender Female	8253 Number of participants
Gender Male	5876 Number of participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 15,268
serious Total, serious adverse events	5 / 15,268

Outcome results

Primary