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

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05450601
• Collaborator: (none)
• Enrollment: 246
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.6
• Patients Per Site Per Month: 15.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: HCP2102-1; Drug: HPP2104-1; Drug: HCP2102-2; Drug: HPP2104-2; Drug: RLD2106-1; Drug: HPP2103-1; Drug: RLD2106-2; Drug: HPP2103-2	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 246 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Doube-blind, Phase III Study to Evaluate the Efficacy and Safety of HCP2102 in Patients With Essential Hypertension
• Actual Study Start Date: Jul 13, 2022
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

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

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 2]

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

3. Change from baseline in mean pulse blood pressure(mmHg) [week 2, 8]

4. Target blood pressure reaching rate(%) [week 2, 8]

5. Blood pressure responder rate(%) [week 2, 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 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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyung Hee University Hospital	Seoul		Korea, Republic of	02447

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: NCT05450601
• Other Study ID Numbers: HM-ALCH-302
• First Posted: Jul 11, 2022
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension; Essential Hypertension

Study Results

No Results Posted as of Aug 2, 2022