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Essential HypertensionPhase 3NCT06121518

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

A Phase 3 study testing D064 and D702, QD in people with Essential Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Essential Hypertension
What is being tested?
D064 and D702, QD
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
235 participants
Where
1 siteSouth Korea
Study dates
31 Jul 2023to 26 Mar 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 140 mmHg ≤ MSSBP(mean sitting SBP) < 180 mmHg
  • Taking antihypertensive drug
  • 130 mmHg ≤ MSSBP(mean sitting SBP) < 180 mmHg
  • Subjects who have voluntarily decided to participate in this clinical trial and signed ICF.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Hanyang University Seoul Hospital

    Seoul, Seongdong-gu, 04763

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

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

Read the detailed description

This study is a Randomized, Double-blind, Multi-center, Therapeutic confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D702 Combination Therapy Versus D064 or D702 Monotherapy in Essential Hypertension Patients

Being tested
D064 and D702, QD, D064 and Placebo of D702, QD, Placebo of D064 and D702, QD
Medical subject headings
Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • D064 and D702, QDDrug

    Also called D064 and D702 Combination Therapy

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

  • D064 and Placebo of D702, QDDrug

    Also called D064 Monotherapy

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

  • Placebo of D064 and D702, QDDrug

    Also called D702 Monotherapy

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

Study groups in NCT06121518
Study groupRoleWhat they receive
Experimental GroupExperimentalD064 and D702 Combination Therapy
Receives: Drug: D064 and D702, QD
Comparator Group 1Active comparatorD064 Monotherapy
Receives: Drug: D064 and Placebo of D702, QD
Comparator Group 2Active comparatorD702 Monotherapy
Receives: Drug: Placebo of D064 and D702, QD

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Compare experimental group with comparator group

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2023
  2. Study start31 Jul 2023
  3. Primary completion22 Mar 2024
  4. Study completion26 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06121518
Sponsor's protocol ID
A30_17HT2222
Status last verified
Apr 2024
First submitted
24 Oct 2023
Last updated
5 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lee SH, Park K, Lee KH, Cho Y, Kim DH, Lim S, Bo Yoon S, Jang JS, Lim HS, Doh JH, Kim DY, Sohn IS, Cheon DY, Bae MH, Kim SH, Lee Y, Ihm SH, Choi RK, Park HJ, Pyun WB, Choi S, Shin J. Efficacy and Safety of Combination Therapy With Low Dose of Telmisartan and S-Amlodipine in Patients With Hypertension: A Randomized, Double-Blind, Multicenter, Therapeutic Confirmatory, Phase III Clinical Trial. Clin Ther. 2026 Mar;48(3):240-246. doi: 10.1016/j.clinthera.2026.01.001. Epub 2026 Feb 10.

    PubMed 41672793

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing D064 and D702, QD in people with Essential Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in MSSBP(mean sitting SBP(systolic blood pressure)) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06121518, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.

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