Hypertension
Conditions
Brief summary
Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy
Detailed description
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy
Interventions
DRUGCKD-330 16/5mg
Once a day, 8 weeks
DRUGAmlodipine 5mg Placebo
Once a day, 8 weeks
DRUGCKD-330 16/5mg Placebo
Once a day, 8 weeks
DRUGAmlodipine 5mg
Once a day, 8 weeks
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age of 19 or above * Essential hypertension with 140mmHg ≤ mean sitSBP \< 180mmHg on target arm at Visit 2 * Ability to provide written informed consent
Exclusion criteria
* The difference between arms of sitSBP ≥ 20mmHg and/or sitDBP ≥ 10mmHg at Visit 1 * mean sitSBP ≥ 200mmHg and/or mean sitDBP ≥ 120mmHg on target arm at Visit 1 * mean sitSBP ≥ 180mmHg and/or mean sitDBP ≥ 120mmHg on target arm at Visit 2 * Known or suspected Secondary Hypertension * Type I Diabetes Mellitus and Type II Diabetes Mellitus with HbA1c \> 9% * Patients with severe congestive heart failure(NYHA class III, IV) * Patient with ischemic heart disease, Ischemic cardiovascular disease, Valvular heart disease, arrhythmia requiring treatment within 3 months * History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months * History of severe or malignant retinopathy * AST/ALT ≥ UNL\*3, Serum creatinine ≥ UNL\*1.5, K \> 5.5mEq/L * Patients with acute or chronic inflammatory status requiring treatment * Patient who need to take antihypertensive drug besides Investigational products * Patient must be treated with medications prohibited for concomitant use during the study period * History of angioedema related to ACE inhibitor or angiotensin II receptor blockers * History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract * History of malignant tumor within 5 years * Patient who are dependent on drugs or alcohol within 6 months * Hypersensitive to Candesartan/Amlodipine * Women with pregnant, breast-feeding * Patients treated with other investigational product within 30 days at first time taking the investigational product * Not eligible to participate for the study at the discretion of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change of sitSBP(sitting Systolic blood pressure) | From baseline at week 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The mean change of sitSBP(sitting Systolic blood pressure) | From baseline at week 4 | — |
| The mean change of sitDBP(sitting diastolic blood pressure) | From baseline at week 4 and week 8 | — |
| Blood Pressure Control rate | From baseline to week 8 | Patient achieving sitSBP \< 140mmHg and sitDBP \< 90mmHg |
| Blood Pressure Response rate | From baseline to week 8 | sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg |
Countries
South Korea
Outcome results
None listed