Hypertension, EssentialPhase 2NCT06826872
Efficacy and Safety of SPC1001 in Patients With Essential Hypertension
A Phase 2 study testing SPC 1001 Mid2, SPC 2002 and SPC 2003 in people with Hypertension, Essential and Cardiovascular Diseases, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to dual-component therapies of each ingredient for 8 weeks. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Hypertension, Essential, Cardiovascular Diseases, Cardiology
- What is being tested?
- SPC 1001 Mid2, SPC 2002 and SPC 2003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jun 2024to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.
Who cannot join
- Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea
Seoul, 06135
ChongJin Kim, MD, chongjinkim@naver.com
ChongJin Kim, MD
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel, Phase 2(2b) Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 in Patients With Essential Hypertension
- Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to dual-component therapies of each ingredient for 8 weeks. Additionally, it seeks to confirm the contribution of each component at low doses.
- Inclusion Criteria: Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.
- Exclusion Criteria: Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.
- Methods: This study is a multicenter, randomized, double-blind, parallel-group, phase 2b clinical trial to evaluate the safety and efficacy of the investigational drug after 8 weeks of administration.
Screening assessments will be conducted within 4 weeks prior to randomization, and patients who meet the inclusion and exclusion criteria at the screening visit will be enrolled in the study after providing informed consent. These participants will undergo a 2-week run-in period during which they will take a placebo and participate in a lifestyle modification program.
- Conditions
- Hypertension, Essential, Cardiovascular Diseases, Cardiology
- Being tested
- SPC 1001 Mid2, SPC 2002, SPC 2003, SPC 2004
- Keywords
- blood pressure, Low-dose combination therapy, candesartan, amlodipine, indapamide
- Medical subject headings
- Essential Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPC 1001 Mid2Drug
low-dose combination therapy
SPC 2002Drug
low-dose combination therapy
SPC 2003Drug
low-dose combination therapy
SPC 2004Drug
low-dose combination therapy
| Study group | Role | What they receive |
|---|---|---|
| SPC 1001 Mid2 | Active comparator | Not described Receives: Drug: SPC 1001 Mid2 |
| SPC2002 | Active comparator | Not described Receives: Drug: SPC 1001 Mid2; Drug: SPC 2002 |
| SPC2003 | Active comparator | Not described Receives: Drug: SPC 1001 Mid2; Drug: SPC 2003 |
| SPC2004 | Active comparator | Not described Receives: Drug: SPC 1001 Mid2; Drug: SPC 2004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8.
Measured: Change from Baseline in MSSBP at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start12 Jun 2024
- Primary completion8 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826872
- Sponsor's protocol ID
- SP-CAP-HTN-202
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned to be publicly available in the form of a future journal submission.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel, Phase 2(2b) Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT06826872
- Acronym / sponsor ID
- SP-CAP-HTN-202
- Conditions
- Hypertension, Essential, Cardiovascular Diseases, Cardiology
- Keywords
- blood pressure, Low-dose combination therapy, candesartan, amlodipine, indapamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 8 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to dual-component therapies of each ingredient for 8 weeks. Additionally, it seeks to confirm the contribution of each component at low doses.
- Inclusion Criteria: Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.
- Exclusion Criteria: Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.
- Methods: This study is a multicenter, randomized, double-blind, parallel-group, phase 2b clinical trial to evaluate the safety and efficacy of the investigational drug after 8 weeks of administration.
Screening assessments will be conducted within 4 weeks prior to randomization, and patients who meet the inclusion and exclusion criteria at the screening visit will be enrolled in the study after providing informed consent. These participants will undergo a 2-week run-in period during which they will take a placebo and participate in a lifestyle modification program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SPC 1001 Mid2 | Active comparator | Drug: SPC 1001 Mid2 |
| SPC2002 | Active comparator | Drug: SPC 1001 Mid2, Drug: SPC 2002 |
| SPC2003 | Active comparator | Drug: SPC 1001 Mid2, Drug: SPC 2003 |
| SPC2004 | Active comparator | Drug: SPC 1001 Mid2, Drug: SPC 2004 |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.
Key exclusion criteria (1 listed)
- Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPC 1001 Mid2low-dose combination therapy | Drug | SPC 1001 Mid2, SPC2002, SPC2003, SPC2004 |
| SPC 2002low-dose combination therapy | Drug | SPC2002 |
| SPC 2003low-dose combination therapy | Drug | SPC2003 |
| SPC 2004low-dose combination therapy | Drug | SPC2004 |
Primary outcome
The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8.
Time frame: Change from Baseline in MSSBP at Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Yes. It is planned to be publicly available in the form of a future journal submission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPC 1001 Mid2, SPC 2002 and SPC 2003 in people with Hypertension, Essential and Cardiovascular Diseases, run by Shin Poong Pharmaceutical Co. Ltd. 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 Feb 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YeongJin Jeong, Master (+82 2-2189-3944, yjjeong@shinpoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8. (time frame: Change from Baseline in MSSBP at Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2025.