CKD-330 Phase 3 Trial in Amlodipine Non-responder

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Amlodipine

Criteria

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