A Study to Evaluate the Efficacy and Safety of HCP2102 in Essential Hypertension Patients

March 4, 2024 updated by: Hanmi Pharmaceutical Company Limited

A Multicenter, Randomized, Doube-blind, Phase III Study to Evaluate the Efficacy and Safety of HCP2102 in Patients With Essential Hypertension

A multicenter, randomized, double-blind, phase III study to evaluate the efficacy and safety of HCP2102 in patients with essential hypertension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged ≥ 19 years
  2. Patients who understands the process of clinical study and voluntarily signs a peer letter

  3. Visit 1: A person whose blood pressure measured in visit 1 corresponds to the following conditions

    • Blood pressure medication taken patients: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg
    • Blood pressure medication free patients: 160mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg
  4. Visit 2: 140mmHg ≤ sitSBP<200mmHg, sitDBP<120mmHg

Exclusion Criteria:

  1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
  2. Orthostatic hypotension with symptoms within 3 months prior to visit 1
  3. Secondary hypertension patient or suspected to be
  4. Uncontrolled diabetes mellitus(HbA1c > 9%) or type I diabetes mellitus
  5. Active gout or hyperuricemia (uric acid ≥ 9mg/dL)
  6. Severe heart disease or severe neurovascular disease
  7. Severe or malignant retinopathy
  8. Clinically significant hematological finding
  9. Severe renal diseases (eGFR<30mL/min/1.73m2)
  10. Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
  11. Hypokalemia or Hyperkalemia(K<3.5mmol/L or K ≥ 5.5mmol/L)
  12. Hyponatremia or Hypernatremia(Na<135mmol/L or Na ≥ 155mmol/L)
  13. Hypercalcemia(Ca ≥ 10.5mg/dL)
  14. History of malignancy tumor
  15. History of autoimmune disease
  16. History of alcohol or drug abuse
  17. Positive to pregnancy test, nursing mother, intention on pregnancy
  18. Considered by investigator as not appropriate to participate in the clinical study with other reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
HCP2102
Drug: HCP2102-1
Take once daily for 2 weeks orally
Drug: HPP2104-1
Placebo drug. Take once daily for 2 weeks orally
Drug: HCP2102-2
Take once daily for 6 weeks orally
Drug: HPP2104-2
Placebo drug. Take once daily for 6 weeks orally
Active Comparator: Active Comparator
RLD2106
Drug: RLD2106-1
Take once daily for 2 weeks orally
Drug: HPP2103-1
Placebo drug. Take once daily for 2 weeks orally
Drug: RLD2106-2
Take once daily for 6 weeks orally
Drug: HPP2103-2
Placebo drug. Take once daily for 6 weeks orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time Frame: week 8
week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean sitting systolic blood pressure(mmHg)
Time Frame: week 2
week 2
Change from baseline in mean sitting diastolic blood pressure(mmHg)
Time Frame: week 2, 8
week 2, 8
Change from baseline in mean pulse blood pressure(mmHg)
Time Frame: week 2, 8
week 2, 8
Target blood pressure reaching rate(%)
Time Frame: week 2, 8
week 2, 8
Blood pressure responder rate(%)
Time Frame: week 2, 8
week 2, 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

December 11, 2023

Study Completion (Actual)

December 11, 2023

Study Registration Dates

First Submitted

July 5, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-ALCH-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on HCP2102-1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe