CKD-828 Primary Hypertension Trial(Dose-selection)

This study has been completed.

Sponsor:

Information provided by:

Chong Kun Dang Pharmaceutical

ClinicalTrials.gov Identifier:

NCT01128322

First received: May 20, 2010

Last updated: April 22, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 20, 2010
Last Updated Date	April 22, 2011
Start Date ^ICMJE	July 2010
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 20, 2010)	Mean Sitting Diastolic Blood Pressure(MSDBP) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01128322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 20, 2010)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	CKD-828 Primary Hypertension Trial(Dose-selection)
Official Title ^ICMJE	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
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Hypertension
Intervention ^ICMJE	Drug: S-Amlodipine, Telmisartan Drug: S-Amlodipine Drug: Telmisartan Drug: Placebo
Study Arm (s)	Experimental: S-Amlodipine 2.5mg + Telmisartan 40mg Intervention: Drug: S-Amlodipine, Telmisartan Experimental: S-Amlodipine 2.5mg + Telmisartan 80mg Intervention: Drug: S-Amlodipine, Telmisartan Experimental: S-Amlodipine 5mg + Telmisartan 40mg Intervention: Drug: S-Amlodipine, Telmisartan Experimental: S-Amlodipine 5mg + Telmisartan 80mg Intervention: Drug: S-Amlodipine, Telmisartan Active Comparator: S-Amlodipine 2.5mg Intervention: Drug: S-Amlodipine Active Comparator: S-Amlodipine 5mg Intervention: Drug: S-Amlodipine Active Comparator: Telmisartan 40mg Intervention: Drug: Telmisartan Active Comparator: Telmisartan 80mg Intervention: Drug: Telmisartan Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	430
Completion Date	March 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01128322
Other Study ID Numbers ^ICMJE	128HT09K
Has Data Monitoring Committee	Not Provided
Responsible Party	Jin Kim / Director
Study Sponsor ^ICMJE	Chong Kun Dang Pharmaceutical
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Chong Kun Dang Pharmaceutical
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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