Clinical Efficacy and Safety Evaluation of HCP1904-1 in Essential Hypertension Patients

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04820907
• Collaborator: (none)
• Enrollment: 116
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.8
• Patients Per Site Per Month: 8.4

Study Details

Study Description

Brief Summary

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

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

Detailed Description

A Multi-center, Randomized, Double-blinded, Active-controlled, Parallel, Phse III Study to Evaluate the Efficacy and Safety of HCP1904-1 in Essential Hypertension Patients

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 116 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 HCP1904-1 in Essential Hypertension Patients.
• Actual Study Start Date: Aug 4, 2020
• Anticipated Primary Completion Date: May 31, 2021
• Anticipated Study Completion Date: Sep 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HCP1904-1	Drug: HCP1904-1; Take it once daily for 8 weeks orally.
Active Comparator: RLD2001-1	Drug: RLD2001-1; Take it 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. Responder rate [Week 4, 8]

5. target blood pressure reach rate [Week 4, 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

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: NCT04820907
• Other Study ID Numbers: HM-CHORUS-301
• First Posted: Mar 29, 2021
• Last Update Posted: Mar 29, 2021
• Last Verified: Mar 1, 2021

• 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 Mar 29, 2021