A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension
Phase 2
- Conditions
- Essential Hypertension
- Interventions
- Registration Number
- NCT02206165
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Candesartan/Amlodipine combined or alone and select better dose of CKD-330 in essential hypertension patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 456
Inclusion Criteria
- Age of 18 or above
- Essential hypertension with 90mmHg ≤ mean sitDBP ≤ 115mmHg on target arm at Visit 3
- Ability to provide written informed consent
Exclusion Criteria
- nean sitDBP ≥ 116mmHg or mean sitSBP ≥ 200mmHg at Visit 1, Visit 2, Visit 3
- The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
- Known or suspected Stage 2 Hypertension (aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- Patients with congestive heart failure(NYHA class III~IV), ischemic heart disease, cardiomyopathy, heart valve disorder, arrhythmia, coronary artery bypass graft
- History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
- Type I Diabets Mellitus, Type II Diabetes Mellitus with HbA1c > 8%
- History of severe or malignant retinopathy
- AST/ALT > UNL * 2, Serum Creatinine > UNL * 1.5, K > 5.5mEq/L
- Patients with acute or chronic inflammatory status, autoimmune disease
- Patients who need to take antihypertensive drug besides Investigational products
- Patients must be treated with medications prohibited for concomitant use during study period
- Hypersensitive to Candesartan/Amlodipine or other dihydropyridine drugs
- Hereditary angioedema or history of angioedema related to ACE inhibitor or angiotensin II receptor blockers
- History of malignant tumor within 5 years
- Patients who are dependent on drugs or alcohol
- History of disability to drug absorption, active inflammatory bowel syndrome with 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
- Patients treated with other investigational product within 4 weeks at the time concents are obtained
- Women with pregnant, breast-feeding
- Not eligible to participate for study at the discretion of investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Candesartan 8mg + Amlodipine 10mg Candesartan 8mg Candesartan 8mg + Amlodipine 10mg, po, q.d. Candesartan 8mg + Amlodipine 5mg Candesartan 8mg Candesartan 8mg + Amlodipine 5mg, po, q.d. Candesartan 16mg + Amlodipine 5mg Candesartan 16mg Candesartan 16mg + Amlodipine 5mg, po, q.d. Candesartan 8mg Candesartan 8mg Candesartan 8mg, po, q.d. Candesartan 16mg Candesartan 16mg Candesartan 16mg, po, q.d. Candesartan 16mg + Amlodipine 10mg Candesartan 16mg Candesartan 16mg + Amlodipine 10mg, po, q.d. Candesartan 16mg + Amlodipine 10mg Amlodipine 10mg Candesartan 16mg + Amlodipine 10mg, po, q.d. Candesartan 8mg + Amlodipine 5mg Amlodipine 5mg Candesartan 8mg + Amlodipine 5mg, po, q.d. Amlodipine 10mg Amlodipine 10mg Amlodipine 10mg, po, q.d. Candesartan 8mg + Amlodipine 10mg Amlodipine 10mg Candesartan 8mg + Amlodipine 10mg, po, q.d. Candesartan 16mg + Amlodipine 5mg Amlodipine 5mg Candesartan 16mg + Amlodipine 5mg, po, q.d. Amlodipine 5mg Amlodipine 5mg Amlodipine 5mg, po, q.d.
- Primary Outcome Measures
Name Time Method The mean change of sitDBP (sitting diastolic blood pressure) From baseline at week 8
- Secondary Outcome Measures
Name Time Method The mean change of sitSBP From baseline at week 4 and 8 Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg From baseline at week 4 and 8 The mean change of sitDBP From baseline at week 4 and week 8 Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg At week 4 and 8
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of