An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy

Study Overview
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Brief Summary
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The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.

Official Title
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8 Week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg+ Amlodipine 5 mg vs. Amlodipine 5mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan80mg+Amlodipine5mg
* Drug: amlodipine 5mg
* Drug: Telmisartan80mg+Amlodipine 5mg


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: diagnosis of essential hypertension failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy provision of written informed consent Exclusion criteria: 1. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan80mg+Amlodipine5mg<br>combination therapy | Drug: Telmisartan80mg+Amlodipine5mg<br>* combination therapy<br>|
| Active Comparator: amlodipine 5 mg<br>Monotherapy | Drug: amlodipine 5mg<br>* monotherapy<br>Drug: Telmisartan80mg+Amlodipine 5mg<br>* combination therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in DBP After 8 Weeks of Treatment | Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint. | Baseline and 8 weeks | 
| Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients | Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in SBP After 8 Weeks of Treatment | Seated trough SBP after 8 weeks or LOCF. Analysis will be adjusted for treatment, country, and baseline measurement of endpoint. | Baseline and 8 weeks | 
| DBP and SBP Control and Response After 8 Weeks of Treatment | DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg. | Baseline and 8 weeks | 
| Number of Patients in Blood Pressure Categories Over Time | BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg. | 8 weeks | 
| Change From Baseline in DBP After 4 Weeks of Treatment | Seated trough DBP after 4 weeks. | Baseline and 4 weeks | 
| Change From Baseline in SBP After 4 Weeks of Treatment | Seated trough SBP after 4 weeks. | Baseline and 4 weeks | 
| DBP and SBP Control and Response After 4 Weeks of Treatment | DBP control is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment. SBP control is defined as SBP <140 mmHg or <130 mmHg in patients with diabetes or renal impairment. DBP response is defined as DBP <90 mmHg or <80 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=10mmHg. SBP response is defined as SBP<140 mmHg or <130 mmHg in patients with diabetes or renal impairment or a reduction from baseline >=15mmHg. | Baseline and 4 weeks | 
| Number of Patients in Blood Pressure Categories at 4 Weeks | BP optimal: SBP <120 mmHg and DBP <80 mmHg, BP normal: SBP <130 mmHg and DBP <85 mmHg but not optimal, BP high-normal: SBP <140 mmHg and DBP <90 mmHg but not normal. Grade 1 hypertension: SBP <160 mmHg and DBP <100 mmHg but not high-normal, Grade 2 hypertension: SBP <180 mmHg and DBP <110 mmHg but not grade 1, Grade 3 hypertension: SBP >=180 mmHg or DBP >=110 mmHg. | 4 weeks | 
| Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG. | Clinically relevant abnormalities for Physical examination, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. | From drug administration until end of treatment plus one day |