The Efficacy of a Combination of Telmisartan/S-Amlodipine Compared With Telmisartan Monotherapy

Study Overview
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Brief Summary
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The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy

Detailed Description
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A multicenter, Prospective, Randomized, Open-label, Phase 4 Trial designed to Evaluate the Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telminuvo®Tab. 40/2.5mg
* Drug: Telmitrend®Tab. 80mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 19 years in hypertension patient Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization Clinic MSSBP ≥ 140mmHg Clinic MSSBP ≥ 130mmHg in diabetes mellitus or chronic kidney disease Diabetes mellitus Before screening, diagnosed with diabetes mellitus being treated with oral hypoglycemic agents at least 30 days OR Patients who meet the following results of laboratory tests at the time of randomization. : Fasting plasma glucose ≥ 126mg/dL Chronic kidney disease Patients who meet the following results of laboratory tests at the time of randomization.: 15mL/min/1.73m2 ≤ estimated glomerular filtration rate ≤ 60mL/min/1.73m2 Patient who decided to participate and signed on an informed consent form willingly Exclusion Criteria: Clinic MSSBP ≥ 200mmHg or Clinic MSDBP ≥ 120mmHg 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 Abnormal laboratory test results Aspartate aminotransferase/Alanine aminotransferase > Upper normal limit X 3 Serum creatinine > Upper normal limit X 4 Secondary hypertension patient without diabetes mellitus, chronic kidney disease: coarctation of aorta, cushing's syndrome, pheochromocytoma, primary aldosteronism etc. 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 Patient who is planning for a renal transplantation during the trial Severe or malignant retinopathy Acute of chronic inflammatory status requiring treatment A history of cancer within five years A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers Severe hypersensitivity to amlodipine or telmisartan 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 Need for other antihypertensive drugs during the trial Need for prohibited medication specified in the protocol Administration of other Investigational Product within 30 days History of drug or alcohol abuse within 6 months Pregnant, breast-feeding and childbearing age who don't use adequate contraception Another clinical condition in investigator's judgement

Ages Eligible for Study
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Minimum Age: 19 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: Telminuvo®Tab. 40/2.5mg<br>Telminuvo®Tab.(Telmisartan/S-Amlodipine) 40/2.5mg | Drug: Telminuvo®Tab. 40/2.5mg<br>* Telminuvo®Tab. 40/2.5mg, Once daily, 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: Telmitrend®Tab. 80mg<br>Telmitrend®Tab.(Telmisartan) 80mg | Drug: Telmitrend®Tab. 80mg<br>* Telmitrend®Tab. 80mg, Once daily, Per oral for 8weeks after 2 4weeks run-in period with Telmitrend®Tab. 40mg<br>* Other names: Telmisartan 80mg;|

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. |  | 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. | Each timepoint is as following: 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(MSSBP)<140mmHg and Mean sitting diastolic blood pressure(MSDBP)<90mmHg (If Hypertension with Diabetes mellitus or Chronic kidney disease: MSSBP<130mmHg and MSDBP<80mmHg) | Baseline and week 8 | 
| 24hr ABPM and Clinic BP response at week 8. | <24hr ABPM> 24hr mean SBP and DBP reduction≥10mmHg <Clinic BP> MSSBP and MSDBP≥10mmHg | Baseline and week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telminuvo, Telmitrend, Hypertension, 24hr ABPM, Telmisartan, S-amlodipine