CKD-828 Primary Hypertension Trial(Dose-selection) - Full Text View

Purpose

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).

Condition	Intervention	Phase
Hypertension	Drug: S-Amlodipine, Telmisartan Drug: S-Amlodipine Drug: Telmisartan Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Telmisartan

U.S. FDA Resources

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:

Mean Sitting Diastolic Blood Pressure(MSDBP) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean Sitting Diastolic Blood Pressure(MSDBP) [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: Yes ]
Mean Sitting Systolic Blood Pressure(MSSBP) [ Time Frame: After 4 weeks and 8 weeks of treatment ] [ Designated as safety issue: Yes ]
Response rate [ Time Frame: After 4 weeks and 8 weeks of treatment ] [ Designated as safety issue: Yes ]
Reduction of SBP ≥ 20mmHg, DBP ≥ 10mmHg
Control rate [ Time Frame: After 4 weeks and 8 weeks of treatment ] [ Designated as safety issue: Yes ]
Reduction SBP < 140mmHg, DBP < 90mmHg

Estimated Enrollment:	430
Study Start Date:	July 2010
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: S-Amlodipine 2.5mg + Telmisartan 40mg	Drug: S-Amlodipine, Telmisartan
Experimental: S-Amlodipine 2.5mg + Telmisartan 80mg	Drug: S-Amlodipine, Telmisartan
Experimental: S-Amlodipine 5mg + Telmisartan 40mg	Drug: S-Amlodipine, Telmisartan
Experimental: S-Amlodipine 5mg + Telmisartan 80mg	Drug: S-Amlodipine, Telmisartan
Active Comparator: S-Amlodipine 2.5mg	Drug: S-Amlodipine
Active Comparator: S-Amlodipine 5mg	Drug: S-Amlodipine
Active Comparator: Telmisartan 40mg	Drug: Telmisartan
Active Comparator: Telmisartan 80mg	Drug: Telmisartan
Placebo Comparator: Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128322

Locations

Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Korea, Republic of
Soonchunhyang University Hospital in Bucheon
Bucheon, Korea, Republic of
Kosin University Gospel Hospital
Busan, Korea, Republic of
Chungbuk National Uiversity Hospital
Cheongju, Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
Goyang, Korea, Republic of
DonGuk University International Hospital
Goyang, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Gachon University Gil Medical Center
Inchon, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Kyung Hee University Medical Center
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
St. Paul's Hospital, The catholic University of Korea
Seoul, Korea, Republic of
Ewha Womans University Hospital
Seoul, Korea, Republic of
Seoul St. Mary's Hospital, The catholic University of Korea
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Soon Chun Hyang University Hospital
Seoul, Korea, Republic of
Kandong Sacred Heart Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Uijeongbu St. Mary's Hospital, The catholic University of Korea
Uijeongbu, Korea, Republic of
Wonju Christian Hospital
Wonju, Korea, Republic of

Sponsors and Collaborators

Chong Kun Dang Pharmaceutical

More Information

No publications provided

Responsible Party:	Jin Kim / Director
ClinicalTrials.gov Identifier:	NCT01128322 History of Changes
Other Study ID Numbers:	128HT09K
Study First Received:	May 20, 2010
Last Updated:	April 22, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:

CKD-828
Hypertension
Primary Hypertension
S-Amlodipine

Telmisartan
Amlodipine
Factorial
Phase 2

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Benzoates
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents

Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 21, 2013