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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

May 20, 2010
April 22, 2011
July 2010
March 2011   (final data collection date for primary outcome measure)
Mean Sitting Diastolic Blood Pressure(MSDBP) [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01128322 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
CKD-828 Primary Hypertension Trial(Dose-selection)
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: S-Amlodipine, Telmisartan
  • Drug: S-Amlodipine
  • Drug: Telmisartan
  • Drug: Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
430
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01128322
128HT09K
Not Provided
Jin Kim / Director
Chong Kun Dang Pharmaceutical
Not Provided
Not Provided
Chong Kun Dang Pharmaceutical
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP