Open Label Study Telmisartan and Amlodipine in Hypertension

Study Overview
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Brief Summary
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The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.

Official Title
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An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: telmisartan/amlodipine 40/5 mg fixed combination
* Drug: telmisartan/amlodipine 80/5 mg fixed combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged at least 18 years diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial. failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial. Exclusion Criteria: pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg discontinuation from the preceding trial because of any adverse event or any other reason known or suspected secondary hypertension mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood Pressure => 120 mmHg at any visit

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: telmisartan/amlodipine 40/5 mg fixed combination|nan|
|Drug: telmisartan/amlodipine 80/5 mg fixed combination|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Seated Diastolic Blood Pressure (DBP) Control | The number of patients who reach the target DBP of <90mmHg | End of study (34 weeks or last value on treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough Seated Systolic Blood Pressure (SBP) Control | The number of patients who reach the target SBP of <140mmHg | End of study (34 weeks or last value on treatment) | 
| Change From Baseline in Trough Seated Diastolic Blood Pressure | Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5. | End of study (34 weeks or last value on treatment) | 
| Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | The difference between the last available troughs represents the additional reduction in DBP in this study | End of study (34 weeks or last value on treatment) | 
| Change From Baseline in Trough Seated Systolic Blood Pressure | Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5. | End of study (34 weeks or last value on treatment) | 
| Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 | The difference between the last available troughs represents the additional reduction in SBP in this study | End of study (34 weeks or last value on treatment) | 
| Trough Seated DBP Response | The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg | End of study (34 weeks or last value on treatment) | 
| Trough Seated SBP Response | The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg | End of study (34 weeks or last value on treatment) | 
| Trough Blood Pressure (BP) Normality Classes | The number of patients who reach predefined BP categories | End of study (34 weeks or last value on treatment) | 
| Time to First Additional Antihypertensive | Time from first intake of medication to first intake of an antihypertensive other than the study drug | At any point during open-label treatment | 
| Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control | The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment | At any point during open-label treatment | 
| Additional Reduction in DBP by Use of Additional Antihypertensive Therapy | Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7 | At any point during open-label treatment | 
| Additional Reduction in SBP by Use of Additional Antihypertensive Therapy | Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7 | At any point during open-label treatment | 
| Trough DBP Control Pre- and Post- Uptitration | The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration | At any point during open-label treatment |