Hypertension
Conditions
Keywords
CKD-828, Hypertension, Stage 2 Hypertension, S-Amlodipine, Telmisartan
Brief summary
The aim of present study is to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.
Detailed description
* In patients with Stage 2 hypertension to determine the efficacy and safety of S-Amlodipine/Telmisartan (2.5/40mg, 2.5/80mg and 5/80mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 10 weeks. * This study is consist of placebo run-in period(2 weeks\_single blind) and treatment period(10 weeks\_double blind.
Interventions
DRUGCKD-828 2.5/40mg
* Fixed dose combination of S-amlodipine 2.5mg and Telmisartan 40mg QD 2 weeks. * With the others investigation product placebo 4 tabs QD 2 weeks.
DRUGCKD-828 5/40mg
* Fixed dose combination of S-amlodipine 5mg and Telmisartan 40mg QD 2 weeks. * With the others investigation product placebo 4 tabs QD 2 weeks.
DRUGCKD-828 5/80mg
* Fixed dose combination of S-amlodipine 5mg and Telmisartan 80mg QD 6 weeks. * With the others investigation product placebo 4 tabs QD 6 weeks.
* S-amlodipine 2.5mg QD 4 weeks * With the others investigation product placebo 4 tabs QD 4 weeks.
DRUGS-amlodipine 5mg
* S-amlodipine 2.5mg QD 6weeks * With the others investigation product placebo 4 tabs QD 6 weeks.
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 diseasesstatus 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Sitting systolic Blood Pressure (MSSBP) | After 10 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Sitting systolic Blood Pressure (MSSBP) | After 2 weeks, 4 weeks and 6 weeks of treatment | — |
| Mean Sitting diastolic Blood Pressure (MSDBP) | After 2weeks, 4weeks, 6weeks and 10 weeks of treatment | — |
| Control Rate | After 10 weeks of treatment | Sitting SBP\<140mmHg, Sitting DBP\<90mmHg |
| Response Rate | After 10 weeks of treatment | Reduction of Sitting SBP≥20mmHg, Sitting DBP ≥10mmHg |
Countries
South Korea
Outcome results
None listed