Telmisartan+Amlodipine Fixed Dose Combination in Hypertension
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|ClinicalTrials.gov Identifier: NCT01204398|
Recruitment Status : Completed
First Posted : September 17, 2010
Results First Posted : August 24, 2012
Last Update Posted : June 27, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: telmisartan+amlodipine fixed dose combination||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Study to Evaluate the Antihypertensive Effects of the Fixed-dose Combination of Telmisartan 80 mg and Amlodipine 5 mg (T80/A5) Given Once Daily by 24 h ABPM in Patients With Moderate to Severe Hypertension|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||July 2011|
Experimental: eligible hypertension patient
Patients will be given placebo for 2 weeks for wash-out, then qualified patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.
Drug: telmisartan+amlodipine fixed dose combination
after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.
- DBP and SBP Change From Baseline in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean [ Time Frame: 8 weeks ]ABPM measurements were taken every 20 minutes throughout the day and night by the validated SpaceLabs Model 90217 monitor.
- Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing [ Time Frame: 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
- Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment [ Time Frame: 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.
- Change From Baseline to End of Study in DBP and SBP [ Time Frame: 8 weeks ]Manually measured in-clinic DBP and SBP
- ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing [ Time Frame: 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 [ Time Frame: 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 In-clinic Pulse Rate [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204398
|1235.31.86001 Boehringer Ingelheim Investigational Site|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|