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CKD-330 Phase 3 Trial in Amlodipine Non-responder

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ClinicalTrials.gov Identifier: NCT02586311
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy

Condition or disease Intervention/treatment Phase
Hypertension Drug: CKD-330 16/5mg Drug: Amlodipine 5mg Placebo Drug: CKD-330 16/5mg Placebo Drug: Amlodipine 5mg Phase 3

Detailed Description:
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a CKD-330 versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a CKD-330 Versus Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by Amlodipine Monotherapy
Study Start Date : January 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CKD-330 16/5mg + Amlodipine 5mg placebo
CKD-330 16/5mg + Amlodipine 5mg placebo, po, q.d.
Drug: CKD-330 16/5mg
Once a day, 8 weeks

Drug: Amlodipine 5mg Placebo
Once a day, 8 weeks
Other Name: Norvasc 5mg Placebo

Active Comparator: CKD-330 16/5mg placebo + Amlodipine 5mg
CKD-330 16/5mg placebo + Amlodipine 5mg, po, q.d.
Drug: CKD-330 16/5mg Placebo
Once a day, 8 weeks

Drug: Amlodipine 5mg
Once a day, 8 weeks
Other Name: Norvasc 5mg




Primary Outcome Measures :
  1. The mean change of sitSBP(sitting Systolic blood pressure) [ Time Frame: From baseline at week 8 ]

Secondary Outcome Measures :
  1. The mean change of sitSBP(sitting Systolic blood pressure) [ Time Frame: From baseline at week 4 ]
  2. The mean change of sitDBP(sitting diastolic blood pressure) [ Time Frame: From baseline at week 4 and week 8 ]
  3. Blood Pressure Control rate [ Time Frame: From baseline to week 8 ]
    Patient achieving sitSBP < 140mmHg and sitDBP < 90mmHg

  4. Blood Pressure Response rate [ Time Frame: From baseline to week 8 ]
    sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 19 or above
  • Essential hypertension with 140mmHg ≤ mean sitSBP < 180mmHg on target arm at Visit 2
  • Ability to provide written informed consent

Exclusion Criteria:

  • The difference between arms of sitSBP ≥ 20mmHg and/or sitDBP ≥ 10mmHg at Visit 1
  • mean sitSBP ≥ 200mmHg and/or mean sitDBP ≥ 120mmHg on target arm at Visit 1
  • mean sitSBP ≥ 180mmHg and/or mean sitDBP ≥ 120mmHg on target arm at Visit 2
  • Known or suspected Secondary Hypertension
  • Type I Diabetes Mellitus and Type II Diabetes Mellitus with HbA1c > 9%
  • Patients with severe congestive heart failure(NYHA class III, IV)
  • Patient with ischemic heart disease, Ischemic cardiovascular disease, Valvular heart disease, arrhythmia requiring treatment within 3 months
  • History of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
  • History of severe or malignant retinopathy
  • AST/ALT ≥ UNL*3, Serum creatinine ≥ UNL*1.5, K > 5.5mEq/L
  • Patients with acute or chronic inflammatory status requiring treatment
  • Patient who need to take antihypertensive drug besides Investigational products
  • Patient must be treated with medications prohibited for concomitant use during the study period
  • History of angioedema related to ACE inhibitor or angiotensin II receptor blockers
  • History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
  • History of malignant tumor within 5 years
  • Patient who are dependent on drugs or alcohol within 6 months
  • Hypersensitive to Candesartan/Amlodipine
  • Women with pregnant, breast-feeding
  • Patients treated with other investigational product within 30 days at first time taking the investigational product
  • Not eligible to participate for the study at the discretion of investigator

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): NCT02586311


Locations
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Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Chang Gyu Park, M.D, Ph.D Korea University Guro Hospital

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02586311     History of Changes
Other Study ID Numbers: 144HT15027
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents