Clinical trial NCT02206165: A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension
Official title: A Randomized, Double-blind, Multi-center, Phase 2 Trial to Evaluate the Efficacy and Safety of Candesartan/Amlodipine Combined or Alone and Select Better Dose of CKD-330 in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Essential Hypertension
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2014-08-01
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: The mean change of sitDBP (sitting diastolic blood pressure)
timeFrame: From baseline at week 8
Secondary outcomes:
measure: The mean change of sitDBP
timeFrame: From baseline at week 4 and week 8
measure: The mean change of sitSBP
timeFrame: From baseline at week 4 and 8
measure: Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg
timeFrame: From baseline at week 4 and 8
measure: Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg
timeFrame: At week 4 and 8
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Cheol-Ho Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: