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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01426100 |
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Date of registration:
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30/08/2011 |
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Primary sponsor: |
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Public title:
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CKD-828 Telmisartan Non-Responder Trial
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Scientific title:
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A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Telmisartan and S-Amlodipine(CKD-828) Versus Telmisartan Monotherapy in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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183 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01426100 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age 18 years or older
- diagnosis of essential hypertension and blood pressure not adequately
controlled(inadequate control defined as seated diastolic blood pressure(DBP)>=
90mmHg if on existing antihypertensive treatment of seated DBP >= 100mmHg if
treatment naive)
- failure to respond to four weeks treatment with telmisartan 40mg(failure to respond
defined as seated DBP >= 90mmHg)
- willing and able to provide written informed consent
Exclusion Criteria:
- mean seated DBP >= 120mmHg and/or mean seated SBP >= 200mmHg during run-in treatment
or mean seated DBP >= 120mmHg and/or mean seated SBP >= 180mmHg at the randomization
visit
- 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 Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as
defined by fasting glucosylated hemoglobin(HbA1c) > 8%
- nown 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 within 6 months
- 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, gastric
ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic
function such as pancreatitis, obstructions of the urinary tract or difficulty in
voiding
- administration of other study drugs within 30 days prior to randomization
- premenopausal women(last menstruation < 1year) not using adequate contraception,
pregnant or breast-feeding
- history of malignancy including leukemia and lymphoma within the past 5 years
- in investigator's judgment
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: CKD-828 40/2.5mg
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Drug: CKD-828 40/5mg
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Drug: Telmisartan 80mg
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Primary Outcome(s)
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Mean Sitting Diastolic Blood Pressure (MSDBP)
[Time Frame: After 8 weeks of treatment]
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Secondary Outcome(s)
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Control rate
[Time Frame: After 4 weeks and 8 weeks of treatment]
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Mean Sitting Diastolic Blood Pressure (MSDBP)
[Time Frame: After 4 weeks of treatment]
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Mean Sitting Systolic Blood Pressure (MSSBP)
[Time Frame: After 4 weeks and 8 weeks of treatment]
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Response rate
[Time Frame: After 4 weeks and 8 weeks of treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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