Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension

Study Overview
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Brief Summary
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The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.

Official Title
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An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).

Conditions
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Hypertension

Intervention / Treatment
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* Drug: amlodipine
* Drug: telmisartan
* Drug: telmisartan and amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation Age 18 years or older Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion) Exclusion criteria Mean in-clinic seated cuff SBP >/= 200 mmHg and/or Diastolic Blood Pressure [DBP] >/= 95 mmHg

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: telmisartan and amlodipine<br>telmisartan and amlodipine used in combination vs amlodipine or telmisartan | Drug: telmisartan and amlodipine<br>* telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w<br>|
| Active Comparator: amlodipine<br>telmisartan and amlodipine used in combination vs amlodipine or telmisartan | Drug: amlodipine<br>* amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w<br>|
| Active Comparator: telmisartan<br>telmisartan and amlodipine used in combination vs amlodipine or telmisartan | Drug: telmisartan<br>* telmisartan 80mg for the 8w, no titration required<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8 | Overall mean reduction from a common mean baseline in SBP | baseline and week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6 | Overall mean reduction from a common mean baseline in SBP | baseline and week 6 | 
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4 | Overall mean reduction from a common mean baseline in SBP | baseline and week 4 | 
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2 | Overall mean reduction from a common mean baseline in SBP | baseline and week 2 | 
| Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1 | Overall mean reduction from a common mean baseline in SBP | baseline and week 1 | 
| Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8 | Overall mean reduction from a common mean baseline in DBP | baseline and week 8 | 
| Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6 | Overall mean reduction from a common mean baseline in DBP | baseline and week 6 | 
| Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4 | Overall mean reduction from a common mean baseline in DBP | baseline and week 4 | 
| Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2 | Overall mean reduction from a common mean baseline in DBP | baseline and week 2 | 
| Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1 | Overall mean reduction from a common mean baseline in DBP | baseline and week 1 | 
| Patients Achieving Diastolic Blood Pressure Control at Week 1 | Diastolic Blood Pressure Control is defined as achieving DBP < 90mmHg | week 1 | 
| Patients Achieving Diastolic Blood Pressure Control at Week 2 | DBP < 90 mmHg | week 2 | 
| Patients Achieving Blood Pressure Control at Week 1 | Blood Pressure Control is defined as achieving SBP< 140 mmHg and DBP < 90mmHg | week 1 | 
| Patients Achieving Blood Pressure Control at Week 2 | SBP < 140 mmHg and DBP < 90 mmHg | week 2 | 
| Patients Achieving Diastolic Blood Pressure Response at Week 1 | Diastolic Blood Pressure Response is defined as achieving DBP < 90 mmHg or a reduction of >= 10 mmHg | baseline, week 1 | 
| Patients Achieving Diastolic Blood Pressure Response at Week 2 | DBP < 90 mmHg or reduction of >= 10 mmHg | baseline, week 2 | 
| Patients Achieving Systolic Blood Pressure Response at Week 1 | Systolic Blood Pressure Response Control is defined as achieving SBP < 140 mmHg or a reduction of >= 15 mmHg | baseline, week 1 | 
| Patients Achieving Systolic Blood Pressure Response at Week 2 | SBP < 140 mmHg or reduction of >= 15 mmHg | baseline, week 2 | 
| Number of Patients Achieving Various Blood Pressure Response Levels at Week 1 | Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 | week 1 | 
| Number of Patients Achieving Various Blood Pressure Response Levels at Week 2 | Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 | week 2 | 
| Patients Achieving Diastolic Blood Pressure Control at Week 4 | DBP < 90 mmHg | week 4 | 
| Patients Achieving Diastolic Blood Pressure Control at Week 6 | DBP < 90 mmHg | week 6 | 
| Patients Achieving Diastolic Blood Pressure Control at Week 8 | DBP < 90 mmHg | week 8 | 
| Patients Achieving Blood Pressure Control at Week 4 | SBP < 140 mmHg and DBP < 90 mmHg | week 4 | 
| Patients Achieving Blood Pressure Control at Week 6 | SBP < 140 mmHg and DBP < 90 mmHg | week 6 | 
| Patients Achieving Blood Pressure Control at Week 8 | SBP < 140 mmHg and DBP < 90 mmHg | week 8 | 
| Patients Achieving Diastolic Blood Pressure Response at Week 4 | DBP < 90 mmHg or reduction of >= 10 mmHg | baseline, week 4 | 
| Patients Achieving Diastolic Blood Pressure Response at Week 6 | DBP < 90 mmHg or reduction of >= 10 mmHg | baseline, week 6 | 
| Patients Achieving Diastolic Blood Pressure Response at Week 8 | DBP < 90 mmHg or reduction of >= 10 mmHg | baseline, week 8 | 
| Patients Achieving Systolic Blood Pressure Response at Week 4 | SBP < 140 mmHg or reduction of >= 15 mmHg | baseline, week 4 | 
| Patients Achieving Systolic Blood Pressure Response at Week 6 | SBP < 140 mmHg or reduction of >= 15 mmHg | baseline, week 6 | 
| Patients Achieving Systolic Blood Pressure Response at Week 8 | SBP < 140 mmHg or reduction of >= 15 mmHg | baseline, week 8 | 
| Patients Achieving Normal Blood Pressure Response at Week 4 | Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 | week 4 | 
| Patients Achieving Normal Blood Pressure Response at Week 6 | Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 | week 6 | 
| Patients Achieving Normal Blood Pressure Response at Week 8 | Optimal: SBP<120 and DBP< 80; Normal: 120<=SBP<130 and 80<= DBP<85; High normal: 130<=SBP<140 and 85<=DBP<90; High: SBP>=140 or DBP>=90 | week 8 |