Efficacy and Safety of TELMINUVO to Stage 2 Hypertension

Study Overview
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Brief Summary
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The aim of present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.

Detailed Description
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In patients with Stage 2 hypertension to determine the efficacy and safety of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 8 weeks. This study is consist of placebo run-in period(2 weeks_single blind) and treatment period(8 weeks_double blind).

Official Title
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A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Telmisartan and S-Amlodipine(TELMINUVO TAB.) Versus S-Amlodipine Monotherapy in Patients With Stage 2 Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: TELMINUVO Tab. (80/2.5mg)
* Drug: TELMINUVO Tab. (80/5mg)
* Drug: S-amlodipine 2.5mg
* Drug: S-amlodipine 5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older at the screening visit antihypertensive drugs not taking: 160mmHg ≤ sitSBP < 200mmHg antihypertensive drugs taking: 140mmHg ≤ sitSBP < 180mmHg at the randomization visit(160mmHg ≤ sitSBP < 200mmHg) willing and able to provide written informed consent Exclusion Criteria: mean sitting DBP ≥ 120mmHg or mean sitting SBP ≥ 200mmHg at the screening visit and randomization visit for the past four weeks based on beginning of administration, patients took over four antihypertensive drugs known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma) has severe heart disease(Heart failure NYHA functional class 3, 4), ischaemic heart diseases status need to treatment, myocardiopathy, Valve disease, arrhythmia and so on and operated Coronary angioplasty has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8%) known severe or malignant retinopathy defined by the following laboratory parameters: hepatic dysfunction(AST/ALT > UNL X 3) renal dysfunction(serum creatinine > UNL X 1.5) hypopotassemia(K < 3.0mmol/L) or hyperpotassemia (K>5.5 mmol/L) acute or chronic inflammatory status need to treatment need to additional antihypertensive drugs during the study need to concomitant medications known to affect blood pressure during the study history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers known hypersensitivity related to either study drug history of drug or alcohol dependency within 6 months any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding) administration of other study drugs within 4weeks prior to screening premenopausal women(last menstruation > 1year) not using adequate contraception, pregnant or breast-feeding history of malignancy including leukemia and lymphoma within the past 5 years in investigator's judgment

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TELMINUVO Tab. (80/2.5mg, 80/5mg)<br> | Drug: TELMINUVO Tab. (80/2.5mg)<br>* Fixed dose combination of Telmisartan 80mg and S-amlodipine 2.5mg QD 2 weeks. With the others investigation product placebo 1 tab QD 2 weeks.<br>* Other names: TELMINUVO Tab.;Drug: TELMINUVO Tab. (80/5mg)<br>* Fixed dose combination of Telmisartan 80mg and S-amlodipine 5mg QD 6 weeks. With the others investigation product placebo 1 tab QD 6 weeks.<br>* Other names: TELMINUVO Tab.;|
| Active Comparator: S-Amlodipine 2.5, 5mg<br> | Drug: S-amlodipine 2.5mg<br>* S-amlodipine 2.5mg QD 2 weeks With the others investigation product placebo 1 tab QD 2 weeks.<br>* Other names: Anydipine S;Drug: S-amlodipine 5mg<br>* S-amlodipine 5mg QD 6weeks With the others investigation product placebo 1 tab QD 6 weeks.<br>* Other names: Anydipine S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sitting Systolic Blood Pressure (MSSBP) |  | After 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Sitting Systolic Blood Pressure (MSSBP) |  | After 2 weeks and 4 weeks of treatment | 
| Mean Sitting Diastolic Blood Pressure (MSDBP) |  | After 2weeks, 4weeks and 8 weeks of treatment | 
| Control Rate | Sitting SBP<140mmHg, Sitting DBP<90mmHg | After 8 weeks of treatment | 
| Response Rate | Reduction of Sitting SBP≥20mmHg, Sitting DBP ≥10mmHg | After 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TELMINUVO Tab., CKD-828, Hypertension, Stage 2 Hypertension, S-Amlodipine, Telmisartan