CKD-330 Phase 3 Trial in Amlodipine Non-responder

Chong Kun Dang

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: CKD-330 16/5mg Placebo; Drug: CKD-330 16/5mg; Drug: Amlodipine 5mg Placebo; Drug: Amlodipine 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02586311

144HT15027

Details and patient eligibility

About

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

Full 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

Enrollment: 160 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

CKD-330 16/5mg + Amlodipine 5mg placebo

Experimental group

Description:

CKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d.

Treatment:

Drug: Amlodipine 5mg Placebo

Drug: CKD-330 16/5mg

CKD-330 16/5mg placebo + Amlodipine 5mg

Active Comparator group

Description:

CKD-330 16/5mg placebo + Amlodipine 5mg, po, q.d.

Treatment:

Drug: CKD-330 16/5mg Placebo

Drug: Amlodipine 5mg