CKD-330 Phase 3 Trial in Amlodipine Non-responder
Phase 3
Completed
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT02586311
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CKD-330 16/5mg + Amlodipine 5mg placebo CKD-330 16/5mg CKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d. CKD-330 16/5mg + Amlodipine 5mg placebo Amlodipine 5mg Placebo CKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d. CKD-330 16/5mg placebo + Amlodipine 5mg CKD-330 16/5mg Placebo CKD-330 16/5mg placebo + Amlodipine 5mg, po, q.d. CKD-330 16/5mg placebo + Amlodipine 5mg Amlodipine 5mg CKD-330 16/5mg placebo + Amlodipine 5mg, po, q.d.
- Primary Outcome Measures
Name Time Method The mean change of sitSBP(sitting Systolic blood pressure) From baseline at week 8
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of