Clinical Trial to Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy

NCT06121518 | Completed Phase 3

• 1 other identifier: A30_17HT2222
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

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

  Compare experimental group with comparator group

  8 weeks

Study Arms (3)

Experimental Group

EXPERIMENTAL

D064 and D702 Combination Therapy

Drug: D064 and D702, QD

Comparator Group 1

ACTIVE COMPARATOR

D064 Monotherapy

Drug: D064 and Placebo of D702, QD

Comparator Group 2

ACTIVE COMPARATOR

D702 Monotherapy

Drug: Placebo of D064 and D702, QD

Interventions

D064 and D702, QD DRUG

Experimental Group Subjects assigned to this group are treated with D064, D702

Also known as: D064 and D702 Combination Therapy

Experimental Group

D064 and Placebo of D702, QD DRUG

Comparator Group Subjects assigned to this group are treated with D064, placebo of D702

Also known as: D064 Monotherapy

Comparator Group 1

Placebo of D064 and D702, QD DRUG

Comparator Group Subjects assigned to this group are treated with D702, placebo of D064

Also known as: D702 Monotherapy

Comparator Group 2

Eligibility Criteria

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

You may qualify if:

• Subjects who are 19 years old or older.
• Subjects who are mean blood pressure measured in the arm selected as the reference arm meets the following criteria:
• Didn't take antihypertensive drug
• mmHg ≤ MSSBP(mean sitting SBP) \< 180 mmHg
• Taking antihypertensive drug
• mmHg ≤ MSSBP(mean sitting SBP) \< 180 mmHg
• Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.

You may not qualify if:

• Subjects with a history of secondary hypertension or suspected secondary hypertension
• Subjects with symptomatic orthostatic hypotension
• Subjects with type 1 diabetes or diabetes that is not adequately controlled (HbA1c \> 9.0%)
• Subjects with Severe heart failure(NYHA Class 3,4) etc.,
• Subjects with a history of unstable angina, moderate or malignant retinopathy, etc., within 6 months at the time of screening
• Subjects with a history of disability to investigational product ADME at the time of screening
• Subjects with abnormalities in laboratory test results at the time of screening
• Subjects with hypersensitivity or history of investigational product and similar drugs
• Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period
• Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening
• Subjects who received other investigational product within 4 weeks of screening visit
• Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last investigational product
• Subjects who are unable to participate in this clinical trial at the discretion of the investigator

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Hanyang University Seoul Hospital

Seoul, Seongdong-gu, 04763, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

2-(3,4-dimethoxyphenyl)-8-(4-hydroxy-3-methoxyphenyl)-6-methyl-2-isopropyl-6-azaoctanitrile

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jinho Shin, M.D, Ph.D

  Hanyang University Seoul Hospital

  PRINCIPAL INVESTIGATOR

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: October 24, 2023
• First Posted: November 8, 2023
• Study Start: July 31, 2023
• Primary Completion: March 22, 2024
• Study Completion: March 26, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

KR (1)