## Protocol Section
### Identification Module
**NCT ID:** NCT06416865

**Brief Title:** Efficacy and Safety of AJU-C52 in Essential Hypertension Patients

**Official Title:** A Randomized, Double-blind, Multi-center, Phase III Trial to Evaluate the Efficacy and Safety of AJU-C52 in Compared With C52R1M for Essential Hypertension Patients in Inappropriately Controlled on C52R1L Treatment

#### Organization Study ID Info
**ID:** 21HT30601
#### Organization
**Class:** INDUSTRY
**Full Name:** AJU Pharm Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2022-12-12

**Type:** ACTUAL

#### Start Date
**Date:** 2022-06-27

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AJU Pharm Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A Randomized, Double-blind, Multi-center, Phase III study to evaluate the efficacy and safety of the AJU-C52 compared with the combination of C52R1M in patients with essential Hypertension Patients who have inappropriately controlled on C52R1L treament

### Conditions Module

**Conditions:**

- Essential Hypertension

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 190

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Treatment Period 1: AJU-C52L+C52R1L placebo

Treatment Period 2: AJU-C52+C52R1M placebo

**Intervention Names:**

- Drug: AJU-C52L, AJU-C52

**Label:** AJU-C52L, AJU-C52

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Treatment Period 1: C52R1L+AJU-C52L placebo

Treatment Period 2: C52R1M+AJU-C52 placebo

**Intervention Names:**

- Drug: C52R1L, C52R1M

**Label:** C52R1L, C52R1M

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- AJU-C52L, AJU-C52

**Description:** AJU-C52L+C52R1L placebo: Subjects take the investigational products once a day for 2 weeks.

AJU-C52+C52R1M placebo: Subjects take the investigational products once a day for 6 weeks.

**Name:** AJU-C52L, AJU-C52

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- C52R1L, C52R1M

**Description:** C52R1L+AJU-C52L placebo: Subjects take the investigational products once a day for 2 weeks.

C52R1M+AJU-C52 placebo: Subjects take the investigational products once a day for 6 weeks.

**Name:** C52R1L, C52R1M

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Changes in MSSBP(mean sitting systolic blood pressure) at the 8th week afeter administration of investigational products from the baseline.

**Measure:** Changes in MSSBP(mean sitting systolic blood pressure)

**Time Frame:** 8th week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adults aged ≤19 years.
* Those who voluntarily signed the informed consent to participate in this study.
* A patient diagnosed with essential hypertension or Patients taking hypertension medication
* Those who are eligible for adequate blood pressure criteria during screening tests: Naïve patient-160 mmHg≤MSSBP\<200 mmHg and MSDBP\<110 mmHg/Patients taking hypertension medication-140 mmHg≤MSSBP\<200 mmHg and MSDBP\<110 mmHg

Exclusion Criteria:

* At the screening visit (Visit 1), patients had 3 blood pressure measurements in the arm with the higher average MSSBP, those whose maximum and minimum blood pressure differences are MSSBP 20 mmHg and MSDBP 10 mmHg
* Secondary hypertension patients or those with a history of suspected secondary hypertension
* Cardiovascular/cerebrovascular disease
* Those with a history of malignant tumor within 5 years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ajuf13001@ajupharm.co.kr

**Name:** INAE PARK

**Phone:** +82-02-2630-0700

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** ajuf13001@ajupharm.co.kr

- **Name:** INAE PARK

- **Phone:** +82-02-2630-0700

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** AJU Pharm Co., Ltd.

**Status:** RECRUITING

### 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

### Intervention Browse Module - Ancestors

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M263171

- Name: Cryptophycin 52

- Relevance: HIGH

- As Found: PNP

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000114033

- Term: Cryptophycin 52

### Misc Info Module

- Version Holder: 2024-05-31
