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

NCT05450601 | Completed Phase 3

• 1 other identifier: HM-ALCH-302
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean sitting systolic blood pressure(mmHg)

  week 8

Secondary Outcomes (5)

• Change from baseline in mean sitting systolic blood pressure(mmHg)

  week 2

• Change from baseline in mean sitting diastolic blood pressure(mmHg)

  week 2, 8

• Change from baseline in mean pulse blood pressure(mmHg)

  week 2, 8

• Target blood pressure reaching rate(%)

  week 2, 8

• Blood pressure responder rate(%)

  week 2, 8

Study Arms (2)

Experimental

EXPERIMENTAL

HCP2102

Drug: HCP2102-1; Drug: HPP2104-1; Drug: HCP2102-2; Drug: HPP2104-2

Active Comparator

ACTIVE COMPARATOR

RLD2106

Drug: RLD2106-1; Drug: HPP2103-1; Drug: RLD2106-2; Drug: HPP2103-2

Interventions

HCP2102-1 DRUG

Take once daily for 2 weeks orally

Experimental

HPP2104-1 DRUG

Placebo drug. Take once daily for 2 weeks orally

Experimental

HCP2102-2 DRUG

Take once daily for 6 weeks orally

Experimental

HPP2104-2 DRUG

Placebo drug. Take once daily for 6 weeks orally

Experimental

RLD2106-1 DRUG

Take once daily for 2 weeks orally

Active Comparator

HPP2103-1 DRUG

Placebo drug. Take once daily for 2 weeks orally

Active Comparator

RLD2106-2 DRUG

Take once daily for 6 weeks orally

Active Comparator

HPP2103-2 DRUG

Placebo drug. Take once daily for 6 weeks orally

Active Comparator

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 19 years
• Patients who understands the process of clinical study and voluntarily signs a peer letter
• 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
• Visit 2: 140mmHg ≤ sitSBP\<200mmHg, sitDBP\<120mmHg

You may not qualify if:

• Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
• Orthostatic hypotension with symptoms within 3 months prior to visit 1
• Secondary hypertension 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(Ca ≥ 10.5mg/dL)
• History of malignancy tumor
• History of autoimmune disease

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 11, 2022
• Study Start: September 1, 2022
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

KR (1)