Clinical EvaluatioN of TElmisartan-based Antihypertensive Regimen

Completed

• Conditions: Hypertension; Metabolic Syndrome X

• Registration Number: NCT00613314
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-12
• Study First Posted: 2008-02-13
• Primary Completion: 2008-04
• Results First Submitted: 2010-02-08
• Results First Submitted QC: 2010-02-08
• Results First Posted: 2010-03-05
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15268

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇵🇭 Vigan City. Ilocos Sur, Philippines