## Protocol Section
### Identification Module
**NCT ID:** NCT06438172

**Acronym:** HM_APOLLO

**Brief Title:** A Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients With Essential Hypertension

**Official Title:** A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HCP1803 Compared to RLD2001-1 in Patients With Essential Hypertension

#### Organization Study ID Info
**ID:** HM-APOLLO-302
#### Organization
**Class:** INDUSTRY
**Full Name:** Hanmi Pharmaceutical Company Limited
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-25

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hanmi Pharmaceutical Company Limited

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HCP1803 compared to RLD2001-1 in patients with essential hypertension

### Conditions Module

**Conditions:**

- Hypertension

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 220

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** HCP1803-3

**Intervention Names:**

- Drug: HCP1803-3

- Drug: HPP2002-1

**Label:** Experimental

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** RLD2001-1

**Intervention Names:**

- Drug: RLD2001-1

- Drug: HPP2003-3

**Label:** Active Comparator

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental

**Description:** Take it once daily for 8 weeks orally.

**Name:** HCP1803-3

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Active Comparator

**Description:** Take it once daily for 8 weeks orally.

**Name:** RLD2001-1

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Active Comparator

**Description:** Placebo drug. Take it once daily for 8 weeks orally.

**Name:** HPP2003-3

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Experimental

**Description:** Placebo drug. Take it once daily for 8 weeks orally.

**Name:** HPP2002-1

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change from baseline in sitting systolic blood pressure

**Time Frame:** baseline, 8 weeks

#### Secondary Outcomes

**Measure:** Change from baseline in sitting systolic blood pressure

**Time Frame:** baseline, 4 weeks

**Measure:** Change from baseline in sitting distolic blood pressure

**Time Frame:** baseline, 4 weeks, 8 weeks

**Measure:** Proportion of subjects achieving blood pressure control

**Time Frame:** 4 weeks, 8 weeks

**Measure:** Blood pressure response rate

**Time Frame:** 4 weeks, 8 weeks

**Measure:** Treatment response rate

**Time Frame:** 4 weeks, 8 weeks

**Measure:** Change from baseline in pulse pressure

**Time Frame:** baseline, 4 weeks, 8 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions

   * mean sitSBP \<180 mmHg and mean sitDBP \< 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1
   * 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1
2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP \< 180 mmHg and 60 mmHg ≤ mean sitDBP \< 110 mmHg at Visit 2

Exclusion Criteria:

1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1
2. Orthostatic hypotension with symptoms within 3 months prior to 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. Moderate or malignant retinopathy
8. Clinically significant hematological finding
9. Severe renal diseases (eGFR\<30mL/min/1.73m2)
10. Severe or active hepatopathy (AST or ALT ≥ 3 times of normal range)
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 other reason

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** skyko7@hanmi.co.kr

**Name:** Na Young Kim

**Phone:** 82-2-410-9165

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Goyang-si

**Contacts:**

***Contact 1:***

- **Email:** mooyong.rhee@gmail.com

- **Name:** Moo-Yong Rhee, M.D., Ph.D.

- **Phone:** 82-31-961-5775

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Donggguk University Ilsan Hospital

**State:** Gyeonggi-do

**Status:** RECRUITING

**Zip:** 10326

#### Overall Officials

**Official 1:**

**Affiliation:** Donggguk University Ilsan Hospital

**Name:** Moo-Yong Rhee, M.D., Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M1470

- Name: Essential Hypertension

- Relevance: HIGH

- As Found: Essential Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006973

- Term: Hypertension

- ID: D000075222

- Term: Essential Hypertension

### Misc Info Module

- Version Holder: 2024-05-31
