NCT02586311CompletedPhase 3
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
Chong Kun Dang Pharmaceutical1 site in 1 country160 target enrollmentStarted: January 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- The mean change of sitSBP(sitting Systolic blood pressure)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CKD-330 16/5mg + Amlodipine 5mg placebo
Experimental
CKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d.
Intervention: CKD-330 16/5mg (Drug)
CKD-330 16/5mg + Amlodipine 5mg placebo
Experimental
CKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d.
Intervention: Amlodipine 5mg Placebo (Drug)
CKD-330 16/5mg placebo + Amlodipine 5mg
Active Comparator
CKD-330 16/5mg placebo + Amlodipine 5mg, po, q.d.
Intervention: CKD-330 16/5mg Placebo (Drug)
CKD-330 16/5mg placebo + Amlodipine 5mg
Active Comparator
CKD-330 16/5mg placebo + Amlodipine 5mg, po, q.d.
Intervention: Amlodipine 5mg (Drug)
Outcomes
Primary Outcomes
The mean change of sitSBP(sitting Systolic blood pressure)
Time Frame: From baseline at week 8
Secondary Outcomes
- 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)
- Blood Pressure Response rate(From baseline to week 8)
Investigators
Study Sites (1)
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