CKD-828 Telmisartan Non-Responder Trial

Study Overview
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Brief Summary
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The aim of the present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (40/2.5mg and 40/5mg) compared with telmisartan monotherapy (80mg) in hypertensive patients inadequately controlled by telmisartan monotherapy.

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(CKD-828) Versus Telmisartan Monotherapy in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy

Conditions
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Hypertension

Intervention / Treatment
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* Drug: CKD-828 40/2.5mg
* Drug: CKD-828 40/5mg
* Drug: Telmisartan 80mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older diagnosis of essential hypertension and blood pressure not adequately controlled(inadequate control defined as seated diastolic blood pressure(DBP)>= 90mmHg if on existing antihypertensive treatment of seated DBP >= 100mmHg if treatment naive) failure to respond to four weeks treatment with telmisartan 40mg(failure to respond defined as seated DBP >= 90mmHg) willing and able to provide written informed consent Exclusion Criteria: mean seated DBP >= 120mmHg and/or mean seated SBP >= 200mmHg during run-in treatment or mean seated DBP >= 120mmHg and/or mean seated SBP >= 180mmHg at the randomization visit 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), unstable angina or myocardial infarction, arrhythmia within the past three months 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% nown severe or malignant retinopathy hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT > UNL X 2, serum creatinine > UNL X 1.5 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 30 days prior to randomization 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: CKD-828 40/2.5mg<br> | Drug: CKD-828 40/2.5mg<br>* Fixed dose combination of Telmisartan 40mg and S-Amlodipine 2.5mg<br>|
| Experimental: CKD-828 40/5mg<br> | Drug: CKD-828 40/5mg<br>* Fixed dose combination of Telmisartan 40mg and S-Amlidioine 5mg<br>|
| Active Comparator: Telmisartan 80mg<br> | Drug: Telmisartan 80mg<br>* Telmisartan 80mg monotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD-828, Hypertension, Primary Hypertension, S-Amlodipine, Telmisartan, Amlodipine, Non-Responder