Telmisartan+Amlodipine Fixed Dose Combination in Hypertension

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: telmisartan+amlodipine fixed dose combination

• Registration Number: NCT01204398
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to severe hypertension

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Study Start: 2010-11
• Primary Completion: 2011-07
• Results First Submitted: 2012-07-20
• Results First Submitted QC: 2012-07-20
• Results First Posted: 2012-08-24
• Status Verified: 2013-12
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
eligible hypertension patient	telmisartan+amlodipine fixed dose combination	Patients will be given placebo for 2 weeks for wash-out, then qualified patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.

Primary Outcome Measures

Name	Time	Method
DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean	8 weeks	ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to End of Study in In-clinic Pulse Rate	8 weeks
Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing	8 weeks	Changes from baseline in DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM after 8 weeks of treatment with T80/A5
ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing	0 and 8 weeks	DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment
Treatment Emergent Adverse Events	8 weeks	Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events
Change From Baseline to End of Study in DBP and SBP	8 weeks	Manually measured in-clinic DBP and SBP
Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment	8 weeks	Calculated on the basis of changes in hourly means from baseline. Trough is defined as the mean of the last three hours of the 24-hour dosing interval. Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing. All measurements are using ABPM.

Trial Locations

Locations (1)

1235.31.86001 Boehringer Ingelheim Investigational Site; 🇨🇳 Shanghai, China