An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

Study Overview
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Brief Summary
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To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy

Official Title
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An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

Conditions
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Hypertension

Intervention / Treatment
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* Drug: telmisartan40/amlodipine5
* Drug: telmisartan80/amlodipine5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with essential hypertension Outpatient Exclusion Criteria: Patients whose SBP >=180 mmHg or DBP >=110 mmHg at the end of treatment visit of the double-blind treatment period in the non-responder trials Patients who have met any of the exclusion criteria defined in the non-responder trials

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: telmisartan40/amlodipine5|nan|
|Drug: telmisartan80/amlodipine5|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Experienced Adverse Events | An adverse event is defined as any untoward medical occurrence | 52 weeks | 
| Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG | Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events. | First administration of study treatment to 24 hours post last dosing of study treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Seated Diastolic Blood Pressure at Week 8 | mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure | Baseline and week 8 | 
| Change From Baseline in Seated Systolic Blood Pressure at Week 8 | mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure | Baseline and week 8 | 
| Seated DBP Control Rate at Trough After 8 Weeks | Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment | week 8 | 
| Seated SBP Control Rate at Trough After 8 Weeks | Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment | Week 8 | 
| Change From Baseline in Seated Diastolic Blood Pressure | Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure | Baseline and week 20 / week 48 | 
| Change From Baseline in Seated Systolic Blood Pressure | mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure | Baseline and week 20 / week 48 | 
| Seated DBP Control Rate at Trough After 6 and 12 Months | Percentage of patients whose DBP <90 mmHg. | 6 months and 12 months | 
| Seated SBP Control Rate at Trough After 6 and 12 Months | Percentage of patients whose SBP <140 mmHg | 6 months and 12 months | 
| Seated DBP Response Rate at Trough | Percentage of patients whose DBP <90 mmHg or decreased from pseudo-baseline by >=10 mmHg at 6 months and 12 months | 6 months and 12 months | 
| Seated SBP Response Rate at Trough | Percentage of patients whose SBP <140 mmHg or decreased deom pseudo-baseline by >=20 mmHg after 6 and 12 months | 6 months and 12 months | 
| Seated Blood Pressure Normalisation at Trough | Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months: Optimal: SBP <120 mmHg and DBP <80 mmHg Normal: SBP >=120 mmHg or DBP >=80 mmHg and SBP <130 mmHg or DBP <85 mmHg High normal: SBP >=130 mmHg or DBP >=85 mmHg and SBP <140 mmHg or DBP <90 mmHg No: SBP >=140 mmHg or DBP >=90 mmHg | 6 months and 12 months |