Efficacy of a Telmisartan/S-Amlodipine on 24-hour BP Control in Hypertensive Patients Inadequately Controlled

Study Overview
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Brief Summary
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To Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine (Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy

Detailed Description
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A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy

Official Title
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A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telminuvo®Tab. 40/2.5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 20 years in hypertension patient Hypertension is satisfied with the Clinic blood pressure that was measured at the time of screening Treatment-Naive: Clinic Mean sitting diastolic blood pressure ≥ 100mmHg. Treatment-Experienced: Clinic Mean sitting diastolic blood pressure ≥ 90mmHg. Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization Clinic Mean sitting diastolic blood pressure ≥ 90mmHg Patient who decided to participate and signed on an informed consent form willingly Exclusion Criteria: Clinic Mean sitting systolic blood pressure ≥ 180mmHg or Clinic Mean sitting diastolic blood pressure ≥ 115mmHg at the time of Screening and Randomization As night workers who sleep during the day and whose working hours including 00:00 to 04:00 Secondary Hypertension Severe heart disease(Heart failure; New York Heart Association(NYHA) class 3, 4) and recent unstable angina or myocardial infarction or valvular heart disease or arrhythmia requiring treatment within the past 3 months Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months type 1 diabetes mellitus or Uncontrolled type 2 diabetes mellitus(HbA1c > 8.0%) Severe or malignant retinopathy Abnormal laboratory test results Aspartate aminotransferase/Alanine aminotransferase > Upper normal limit X 2 Serum creatinine > Upper normal limit X 2 Acute of chronic inflammatory status requiring treatment Need for other antihypertensive drugs during the trial Need for prohibited medication specified in the protocol A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers Severe hypersensitivity to amlodipine or telmisartan History of drug or alcohol abuse within 6 months Surgical or medical conditions History of major gastrointestinal surgery History of active inflammatory bowel syndrome within 12 months Abnormal pancreatic functions Gastrointestinal/rectal bleeding Urinary tract obstruction Administration of other Investigational Product within 30 days Pregnant, breast-feeding and childbearing age who don't use adequate contraception History of malignant tumor within 5 years (including leukemia and lymphoma) Another clinical condition in investigator's judgement

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: night<br>Telminuvo®Tab. 40/2.5mg ,Once daily, from 6 pm to 10 pm, Per oral for 8weeks after 2 4weeks run-in period with Telmitrend®Tab. 40mg | Drug: Telminuvo®Tab. 40/2.5mg<br>* per oral for 8weeks after 2 4weeks run-in period with Telmitrend®Tab. 40mg<br>* Other names: Telmisartan/S-Amlodipine 40/2.5mg;|
| Active Comparator: morning<br>Telminuvo®Tab. 40/2.5mg ,Once daily, from 6 am to 10 am, Per oral for 8weeks after 2 4weeks run-in period with Telmitrend®Tab. 40mg | Drug: Telminuvo®Tab. 40/2.5mg<br>* per oral for 8weeks after 2 4weeks run-in period with Telmitrend®Tab. 40mg<br>* Other names: Telmisartan/S-Amlodipine 40/2.5mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8. | Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8. | Baseline and week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8 | Daytime: 06:00 21:59 Nighttime: 22:00 05:59 Morning: 06:00 11:59 | Baseline and week 8 | 
| Change from baseline in the clinic mean blood pressure at week 8. |  | Baseline and week 8 | 
| 24hr ABPM and Clinic BP control at week 8. | <24hr ABPM> 24hr mean BP: 24hr mean Systolic blood pressure(SBP)<130mmHg and 24hr mean Diastolic blood pressure(DBP)<80mmHg Daytime BP: Daytime mean SBP<135mmHg and Daytime mean DBP<85mmHg Night time BP: Night time mean SBP<120mmHg and Night time mean DBP<70mmHg <Clinic BP> : Mean sitting systolic blood pressure<140mmHg and Mean sitting diastolic blood pressure<90mmHg | Baseline and week 8 | 
| Morning BP Surge | The morning BP surge was calculated as the morning BP minus the lowest BP. Morning BP was defined as the average BP during the first 2 h after waking. The lowest BP was defined as the average of three BP readings focused on the lowest night-time reading (that is, the lowest reading plus the readings immediately before and after) | Baseline and week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, Telmisartan/S-Amlodipine