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CKD-828 S-Amlodipine Non-Responder Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501253
First Posted: December 29, 2011
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
  Purpose
The aim of present study is to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg) in hypertensive patients inadequately controlled by S-Amlodipine monotherapy.

Condition Intervention Phase
Hypertension Drug: CKD-828 2.5/40mg Drug: CKD-828 2.5/80mg Drug: S-Amlodipine 2.5mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluate the Efficacy and Safety of a Fixed Dose Combination of S-Amlodipine and Telmisartan(CKD-828) vs. S-Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by S-Amlodipine Monotherapy.

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: After 4 weeks of treatment ]
  • Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: After 4 weeks and 8 weeks of treatment ]
  • Control Rate [ Time Frame: After 8 weeks of treatment ]
    SBP<140mmHg, DBP<90mmHg

  • Response Rate [ Time Frame: After 8 weeks of treatment ]
    Reduction of SBP≥20mmHg, DBP≥10mmHg


Enrollment: 187
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CKD-828 2.5/40mg
CKD-828 2.5/40mg
Drug: CKD-828 2.5/40mg
fixed dose combination of S-Amlodipine 2.5mg and Telmisartan 40mg
Experimental: CKD-828 2.5/80mg
CKD-828 2.5/80mg
Drug: CKD-828 2.5/80mg
Fixed dose combination of S-Amlodipine 2.5 and Telmisartan 80mg
Active Comparator: S-Amlodipine 2.5mg
S-Amlodipine 2.5mg
Drug: S-Amlodipine 2.5mg
S-Amlodipine 2.5mg monotherapy
Other Name: Anydipine S tab.

Detailed Description:
  • In patients with essential hypertension inadequately controlled by S-Amlodipine monotherapy to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg)during 8weeks.
  • Included S-Amlodipine run-in period(during 4 weeks_single blind) and Treatment period(during 8 weeks_double blind).
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 amtihypertensive treatment of seated DBP≥100mmHg if treatment naive)
  • failure to respond to four weeks treatment with S-Amlodipine 2.5mg(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%
  • 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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501253


Locations
Korea, Republic of
Seoul St. Mary's hospital, The catholic university of Korea
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Ho-Joong Yoon, Ph.D Seoul St. Mary's hospital, The catholic university of Korea
  More Information

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01501253     History of Changes
Other Study ID Numbers: 130HT11A
First Submitted: December 26, 2011
First Posted: December 29, 2011
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by Chong Kun Dang Pharmaceutical:
CKD-828
Hypertension
Primary Hypertension
S-Amlodipine
Telmisartan
Non-Responder

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Amlodipine
Niacin
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs