Clinical Efficacy and Safety Evaluation of HCP1904-2 in Essential Hypertension Patients

Overview

The purpose of this study is to evaluate of efficacy and safety of HCP1904-2 and RLD2001-2 alone in patients with essential hypertension inadequately controlled on RLD2001-2 monotherapy.

Full Title of Study: “A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-2 in Essential Hypertension Patients.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 31, 2021

Detailed Description

A Multi-center, Randomized, Double-blinded, Active-controlled, Parallel, Phse III Study to Evaluate the Efficacy and Safety of HCP1904-2 in Essential Hypertension Patients

Interventions

  • Drug: HCP1904-2
    • Take it once daily for 8 weeks orally.
  • Drug: RLD2001-2
    • Take it once daily for 8 weeks orally.

Arms, Groups and Cohorts

  • Experimental: HCP1904-2
  • Active Comparator: RLD2001-2

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in mean sitting systolic blood pressure(mmHg)
    • Time Frame: Week 8

Secondary Measures

  • Change from baseline in mean sitting systolic blood pressure(mmHg)
    • Time Frame: Week 4
  • Change from baseline in mean sitting diastolic blood pressure(mmHg)
    • Time Frame: Week 4,8
  • Change from baseline in mean pulse blood pressure(mmHg)
    • Time Frame: Week 4,8
  • Responder rate
    • Time Frame: Week 4, 8
  • target blood pressure reach rate
    • Time Frame: Week 4, 8

Participating in This Clinical Trial

Inclusion Criteria

1. Patients over 18 years of age 2. Patients who understands the process of clinical study and voluntarily signs a peer letter 3. Visit1: A person whose blood pressure measured in visit1 corresponds to the following conditions

  • Blood pressure medication taken patients: 130mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg – Blood pressure medication free patients: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg 4. Visit2: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP <180mmHg, sit DBP < 110mmHg Exclusion Criteria:

  • Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP – Orthostatic hypotension with symptoms within 3months of visit 1 – Secondary hypertensive patient or suspected to be – Uncontrolled diabetes mellitus(HbA1c > 9%) or type I diabetes mellitus – Active gout or hyperuricemia (uric acid ≥ 9mg/dL) – Severe heart disease or severe neurovascular disease – Severe or malignant retinopathy – Clinically significant hematological finding – Severe renal diseases (eGFR<30mL/min/1.73m2) – Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times) – Hypokalemia or Hyperkalemia(K<3.5mmol/L or K ≥ 5.5mmol/L) – Hyponatremia or Hypernatremia(Na<135mmol/L or Na ≥ 155mmol/L) – Hypercalcemia – History of malignancy tumor – History of autoimmune disease – History of alcohol or drug abuse – Positive to pregnancy test, nursing mother, intention on pregnancy – Considered by investigator as not appropriate to participate in the clinical study with othe reason

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hanmi Pharmaceutical Company Limited
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Jin-A Jung, Ph.D., 82-2-410-9038, jajung@hanmi.co.kr

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