Telmisartan+Amlodipine Fixed Dose Combination in Hypertension

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: telmisartan+amlodipine fixed dose combination


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Aged at least 18 years at the date of signing the consent form For treatment-naïve patients: hypertension defined by a mean seated diastolic blood pressure (DBP) equal or more than 100 mmHg measured by manual cuff sphygmomanometry at visit 1 and 2; For pretreatment patients: hypertension defined by a mean seated diastolic blood pressure equal or more than 90 mmHg at visit 1 and equal or more than 100 mmHg at visit 2 measured by manual cuff sphygmomanometry 24-hour mean diastolic blood pressure equal or more than 85 mmHg at baseline Ambulatory Blood Pressure Monitoring Exclusion criteria: mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated diastolic blood pressure equal or more than 120 mmHg any clinically significant hepatic impairment severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped other conditions or situations that could put potential participants at unacceptable risk due to participation in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eligible hypertension patient<br>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<br>* after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in ABPM Hourly Mean DBP and SBP, Starting 1 Hour After Dosing | 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 | 8 weeks | 
| Trough to Peak (T/P) Ratio for DBP and SBP After 8 Weeks of Treatment | 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. | 8 weeks | 
| Change From Baseline to End of Study in DBP and SBP | Manually measured in-clinic DBP and SBP | 8 weeks | 
| ABPM Hourly Mean DBP and SBP at Baseline and the End of the Study, Starting 1 Hour After Dosing | DBP and SBP hourly means over the 24-hour dosing interval as measured by ABPM at baseline and after 8 weeks of treatment | 0 and 8 weeks | 
| Treatment Emergent Adverse Events | Electrocardiogram, laboratory parameters and physical examinations were performed and any abnormal findings were recorded within the adverse events | 8 weeks | 
| Change From Baseline to End of Study in In-clinic Pulse Rate |  | 8 weeks |