Clinical trial NCT01128322: CKD-828 Primary Hypertension Trial(Dose-selection)
Official title: A Randomized, Double-blind, Multi-center, Multi-factorial, Phase 2 Trial to Evaluate the Efficacy and Safety of S-Amlodipine/Telmisartan Combined or Alone and Select Better Dose of CKD-828 in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: CKD-828
Hypertension
Primary Hypertension
S-Amlodipine
Telmisartan
Amlodipine
Factorial
Phase 2
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 430
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 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).


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

Primary outcomes:
measure: Mean Sitting Diastolic Blood Pressure(MSDBP)
timeFrame: After 8 weeks of treatment
Secondary outcomes:
measure: Mean Sitting Diastolic Blood Pressure(MSDBP)
timeFrame: After 4 weeks of treatment
measure: Mean Sitting Systolic Blood Pressure(MSSBP)
timeFrame: After 4 weeks and 8 weeks of treatment
measure: Response rate
timeFrame: After 4 weeks and 8 weeks of treatment
measure: Control rate
timeFrame: After 4 weeks and 8 weeks of treatment
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hospital in Bucheon
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National Uiversity Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Goyang
country: Korea, Republic of
facility: DonGuk University International Hospital
city: Goyang
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Inchon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kandong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
city: Seoul
country: Korea, Republic of
facility: St. Paul's Hospital, The catholic University of Korea
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital, The catholic University of Korea
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
Study officials:
References: