CKD-828 Primary Hypertension Trial(Dose-selection)

NCT ID: NCT01128322

Last Updated: 2011-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-03-31

Brief Summary

The aim of this trial is to determine the best dose combination of S-Amlodipine and Telmisartan as compared to monotherapy by assessing the blood pressure lowering effects of a once daily regimen of various combinations of S-Amlodipine and Telmisartan, compared to their monotherapy components and placebo, in patients with stage I or II essential hypertension(a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg).

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

S-Amlodipine 2.5mg + Telmisartan 40mg

Group Type: EXPERIMENTAL

S-Amlodipine, Telmisartan

Intervention Type: DRUG

S-Amlodipine 2.5mg + Telmisartan 80mg

Group Type: EXPERIMENTAL

S-Amlodipine, Telmisartan

Intervention Type: DRUG

S-Amlodipine 5mg + Telmisartan 40mg

Group Type: EXPERIMENTAL

S-Amlodipine, Telmisartan

Intervention Type: DRUG

S-Amlodipine 5mg + Telmisartan 80mg

Group Type: EXPERIMENTAL

S-Amlodipine, Telmisartan

Intervention Type: DRUG

S-Amlodipine 2.5mg

Group Type: ACTIVE_COMPARATOR

S-Amlodipine

Intervention Type: DRUG

S-Amlodipine 5mg

Group Type: ACTIVE_COMPARATOR

S-Amlodipine

Intervention Type: DRUG

Telmisartan 40mg

Group Type: ACTIVE_COMPARATOR

Telmisartan

Intervention Type: DRUG

Telmisartan 80mg

Group Type: ACTIVE_COMPARATOR

Telmisartan

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

S-Amlodipine, Telmisartan

Intervention Type: DRUG

S-Amlodipine

Intervention Type: DRUG

Telmisartan

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age 18 years or older
• stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg
• ability to provide written informed consent

Exclusion Criteria

• severe hypertension defined as: a mean seated cuff diastolic blood pressure >=116mmHg or a mean seated cuff systolic blood pressure >=200mmHg
• known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
• has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months
• has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
• Type I Diabets Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8%
• known severe or malignant retinopathy
• hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT > UNL X 2, serum creatinine > UNL X 1.5
• acute or chronic inflammatory status need to treatment
• need to additional antihypertensive drugs during the study
• need to concomitant medications known to affect blood pressure during the study
• history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
• known hypersensitivity related to either study drug
• history of drug or alcohol dependency
• any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, currently active gatritis, ulcers of gastrointetinal/rectal bleeding, impaired pancreatic fuction such as pancreatitis,obstructions of the urinary tract or difficulty in voiding)
• cannot swallow investigational products
• administration of other study drugs within 4 weeks prior to randomization
• premenopausal women(last menstration < 1year) not using adequte contraception, pregnant or breast-feeding
• history of malignancy including leukemia and lymphoma within the past 5 years
• in investigator's judgment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Locations

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Soonchunhyang University Hospital in Bucheon

Bucheon-si, , South Korea

Kosin University Gospel Hospital

Busan, , South Korea

Chungbuk National Uiversity Hospital

Cheongju-si, , South Korea

Daegu Catholic University Medical Center

Daegu, , South Korea

Keimyung University Dongsan Medical Center

Daegu, , South Korea

DonGuk University International Hospital

Goyang, , South Korea

National Health Insurance Corporation Ilsan Hospital

Goyang, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Gachon University Gil Medical Center

Inchon, , South Korea

Chonbuk National University Hospital

Jeonju, , South Korea

Pusan National University Hospital

Pusan, , South Korea

Seoul National University Bundang Hospital

Seongnam, , South Korea

Ewha Womans University Hospital

Seoul, , South Korea

Gangnam Severance Hospital

Seoul, , South Korea

Kandong Sacred Heart Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Kyung Hee University Medical Center

Seoul, , South Korea

Seoul St. Mary's Hospital, The catholic University of Korea

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Soon Chun Hyang University Hospital

Seoul, , South Korea

St. Paul's Hospital, The catholic University of Korea

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Uijeongbu St. Mary's Hospital, The catholic University of Korea

Uijeongbu-si, , South Korea

Wonju Christian Hospital

Wŏnju, , South Korea

Countries

South Korea

Other Identifiers

128HT09K

Identifier Type: -

Identifier Source: org_study_id