Hypertension (HTN)Phase 2NCT07064525
Evaluate the Efficacy and Safety of SPC1001 Low in Patients With Essential Hypertension
A Phase 2 study testing SPC1001 Low, SPC5002 and SPC5003 in people with Hypertension (HTN) and NYHA Class III Heart Failure, 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 Low) 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 (HTN), NYHA Class III Heart Failure, NYHA Class IV Heart Failure
- What is being tested?
- SPC1001 Low, SPC5002 and SPC5003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Dec 2024to 28 Feb 2026
- 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.
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel, Phase 2b Study to Evaluate the Efficacy and Safety of SPC1001 Low in Patients With Essential Hypertension
- Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001 Low) 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 (HTN), NYHA Class III Heart Failure, NYHA Class IV Heart Failure, Diabete Mellitus
- Being tested
- SPC1001 Low, SPC5002, SPC5003, SPC5004
- Keywords
- blood pressure, phase 2b, low dose combination therapy, candesartan, amlodipine, indapamide
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPC1001 LowDrug
low-dose combination therapy
SPC5002Drug
low-dose combination therapy
SPC5003Drug
low-dose combination therapy
SPC5004Drug
low-dose combination therapy
| Study group | Role | What they receive |
|---|---|---|
| SPC1001 Low | Active comparator | low-dose combination therapy Receives: Drug: SPC1001 Low |
| SPC5002 | Active comparator | low-dose combination therapy Receives: Drug: SPC1001 Low; Drug: SPC5002 |
| SPC5003 | Active comparator | low-dose combination therapy Receives: Drug: SPC1001 Low; Drug: SPC5003 |
| SPC5004 | Active comparator | low-dose combination therapy Receives: Drug: SPC1001 Low; Drug: SPC5004 |
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 in MSSBP from baseline 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 Jul 2025
- Study start5 Dec 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies 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
- NCT07064525
- Sponsor's protocol ID
- SP-CAP-HTN-203
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 14 Jul 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 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel, Phase 2b Study to Evaluate the Efficacy and Safety of SPC1001 Low in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT07064525
- Acronym / sponsor ID
- SP-CAP-HTN-203
- Conditions
- Hypertension (HTN), NYHA Class III Heart Failure, NYHA Class IV Heart Failure, Diabete Mellitus
- Keywords
- blood pressure, phase 2b, low dose combination therapy, candesartan, amlodipine, indapamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 14 Jul 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 Low) 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 |
|---|---|---|
| SPC1001 Low | Active comparator | Drug: SPC1001 Lowlow-dose combination therapy |
| SPC5002 | Active comparator | Drug: SPC1001 Low, Drug: SPC5002low-dose combination therapy |
| SPC5003 | Active comparator | Drug: SPC1001 Low, Drug: SPC5003low-dose combination therapy |
| SPC5004 | Active comparator | Drug: SPC1001 Low, Drug: SPC5004low-dose combination therapy |
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 |
|---|---|---|
| SPC1001 Lowlow-dose combination therapy | Drug | SPC1001 Low, SPC5002, SPC5003, SPC5004 |
| SPC5002low-dose combination therapy | Drug | SPC5002 |
| SPC5003low-dose combination therapy | Drug | SPC5003 |
| SPC5004low-dose combination therapy | Drug | SPC5004 |
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 in MSSBP from baseline 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 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 SPC1001 Low, SPC5002 and SPC5003 in people with Hypertension (HTN) and NYHA Class III Heart Failure, 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: enrolling by invitation, as of the sponsor's last update on 14 Jul 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?
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?
The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8 (time frame: change in MSSBP from baseline 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 Jul 2025.