A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Amlodipine; Candesartan; Candesartan cilexetil

Criteria

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