Clinical Efficacy and Safety Evaluation of HCP1904-3 in Essential Hypertension Patients

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05199129
• Collaborator: (none)
• Enrollment: 158
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.7
• Patients Per Site Per Month: 14.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate of efficacy and safety of HCP1904-3 and RLD2001-1 alone in patients with essential hypertension inadequately controlled on RLD2001-1 monotherapy.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: HCP1904-3; Drug: RLD2001-1	Phase 3

Detailed Description

A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-3 in Essential Hypertension patients

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Randomized, Double-blinded, Active-Controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of HCP1904-3 in Essential Hypertension Patients
• Actual Study Start Date: Nov 8, 2021
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HCP1904-3	Drug: HCP1904-3; Take once daily for 8 weeks orally; Drug: RLD2001-1; Take once daily for 8 weeks orally
Active Comparator: RLD2001-1	Drug: HCP1904-3; Take once daily for 8 weeks orally; Drug: RLD2001-1; Take once daily for 8 weeks orally

Outcome Measures

Primary Outcome Measures

1. Change from baseline in mean sitting systolic blood pressure(mmHg) [Week 8]

Secondary Outcome Measures

1. Change from baseline in mean sitting systolic blood pressure(mmHg) [Week 4]

2. Change from baseline in mean sitting diastolic blood pressure(mmHg) [Week 4,8]

3. Change from baseline in mean pulse blood pressure(mmHg) [Week 4,8]

4. Target blood pressure reach rate(%) [Week 4,8]

5. Blood pressure responder rate(%) [Week 4,8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients over 19 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

1. Visit2: 140mmHg ≤ sitSBP<180mmHg, sitDBP<110mmHg or if patients are in high risk group: 130mmHg ≤ sitSBP <180mmHg, sit DBP < 110mmHg

Exclusion Criteria:

1. Difference in mean value of blood pressure measured in both arms of more than 20mmHg in sitSBP or more than 10mmHg in sitDBP

2. Orthostatic hypotension with symptoms within 3months of visit 1

3. Secondary hypertensive 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

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 othe reason

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT05199129
• Other Study ID Numbers: HM-CHORUS-303
• First Posted: Jan 20, 2022
• Last Update Posted: Jan 20, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hanmi Pharmaceutical Company Limited: Losartan, Chlorthalidone
• Additional relevant MeSH terms: Hypertension; Essential Hypertension

Study Results

No Results Posted as of Jan 20, 2022