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A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605

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ClinicalTrials.gov Identifier: NCT02916602
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
A phase 3 study to evaluate efficacy and safety of HCP1401

Condition or disease Intervention/treatment Phase
Hypertension Drug: HCP1401 Drug: HCP0605 Phase 3

Detailed Description:
A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605
Study Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
HCP1401
Drug: HCP1401
amlodipine, Losartan, Chlorthalidone FDC
Other Name: amlodipine, Losartan, Chlorthalidone

Active Comparator: Reference
HCP0605
Drug: HCP0605
amlodipine, Losartan FDC
Other Name: amlodipine, Losartan




Primary Outcome Measures :
  1. Change from baseline in sitting systolic blood pressure at week 8 [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in sitting diastolic blood pressure at week 2 and week 8 [ Time Frame: 2 weeks and 8 weeks ]
  2. Change from baseline in sitting systolic blood pressure at week 2 [ Time Frame: 2 weeks ]
  3. Proportion of subjects achieving Blood Pressure control [ Time Frame: 2 weeks and 8 weeks ]


Information from the National Library of Medicine

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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:

  • Hypertension patient who satisfied below condition at Visit 1.

    • patient who takes antihypertensive drug

      • 140mmHg <= sitSBP <= 200mmHg
    • patient who doesn't take antihypertensive drug

      • 160mmHg <= sitSBP <= 200mmHg
      • 140mmHg <= sitSBP <= 200mmHg at Visit 2

Exclusion Criteria:

  • Patient who have received 4 or more antihypertensive drug
  • Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1
  • Patient with sitDBP >= 120mmHg at Visit 2
  • Patient with secondary hypertension

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): NCT02916602


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-Do, Korea, Republic of, 463-707
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: Cheulho Kim, M.D.,Ph.D. Seoul National University Bundang Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT02916602     History of Changes
Other Study ID Numbers: HM-ALCH-301
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: September 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
Losartan
Chlorthalidone
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors