Clinical trial NCT02586311: CKD-330 Phase 3 Trial in Amlodipine Non-responder
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-10-26
Enrollment: 160
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: The mean change of sitSBP(sitting Systolic blood pressure)
timeFrame: From baseline at week 8
Secondary outcomes:
measure: The mean change of sitSBP(sitting Systolic blood pressure)
timeFrame: From baseline at week 4
measure: The mean change of sitDBP(sitting diastolic blood pressure)
timeFrame: From baseline at week 4 and week 8
measure: Blood Pressure Control rate
timeFrame: From baseline to week 8
measure: Blood Pressure Response rate
timeFrame: From baseline to week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Chang Gyu Park, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: