A Dose Selection Trial of CKD-330 in Patients With Essential Hypertension

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02206165
• Other study ID #: 144HT13021
• Status: Recruiting
• Phase: Phase 2
• First received: June 16, 2014
• Last updated: March 27, 2015
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: March 2015
• Source: Chong Kun Dang Pharmaceutical
• Contact: HyunKyung Oh
• Phone: 82-2-2194-0469
• Email: hkoh[@]ckdpharm.com
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety(MFDS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 456
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Candesartan 8mg
Once a day, 8 weeks
• Candesartan 16mg
Once a day, 8 weeks
• Amlodipine 5mg
Once a day, 8 weeks
• Amlodipine 10mg
Once a day, 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean change of sitDBP (sitting diastolic blood pressure)		From baseline at week 8	No
Secondary	The mean change of sitDBP		From baseline at week 4 and week 8	No
Secondary	The mean change of sitSBP		From baseline at week 4 and 8	No
Secondary	Responder rate: The change of sitDBP > 10mmHg, sitSBP > 20mmHg		From baseline at week 4 and 8	No
Secondary	Control rate: Patient achieving sitDBP < 90mmHg and sitSBP < 140mmHg		At week 4 and 8	No