HypertensionPhase 2SP-CAP-002NCT06212648
Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension
A Phase 2 study testing SPC1001 High, SPC1001 Mid1 and SPC1001 Mid2 in people with Hypertension and Essential Hypertension, run by Shin Poong Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
This study purpose is to determine the appropriate combination drug dose by comparing safety and efficacy with placebo, candesartan, and amlodipine monotherapy after 8 weeks of administration of SPC1001 to patients with essential hypertension. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Hypertension, Essential Hypertension
- What is being tested?
- SPC1001 High, SPC1001 Mid1 and SPC1001 Mid2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Mar 2022to 27 Jan 2023
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 19 and 75
- Those whose blood pressure measured at the time of screening meets the following criteria 2.1 Not taking antihypertensive drugs (Naïve): 140 mmHg ≤ MSSBP (mean sitting SBP) < 180 mmHg 2.2 If you are taking antihypertensive drugs or have diabetes or chronic kidney disease: 130 mmHg ≤ MSSBP < 180 mmHg
- Those whose blood pressure measured at the time of randomization meets the following criteria 3.1. 140 mmHg ≤ MSSBP < 180 mmHg 3.2. Or patients with diabetes or chronic kidney disease 130 mmHg ≤ MSSBP < 180 mmHg (However, patients with chronic kidney disease who have clinically significant albuminuria or proteinuria within 6 months)
- Those who voluntarily agreed to participate in this clinical trial and signed the consent form
Who cannot join
- Those whose blood pressure measured at screening and randomization is MSDBP (Mean Sitting DBP) ≥ 110 mmHg
- Patients who showed a difference of SBP 20 mmHg or more and DBP 10 mmHg or more in blood pressure measured 3 times in both arms at screening
- Patients with a history of secondary hypertension or any history of suspected secondary hypertension (aortic stenosis, primary hyperaldosteronemia, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)
- Patients with symptomatic orthostatic hypotension
- Patients requiring concomitant administration of other antihypertensive drugs in addition to investigational drugs during clinical trial participation (Diuretics, β-blockers, ACE inhibitors, Angiotensin II Receptor Blocker, Calcium Channel Blockers, α-blockers, Renin Inhibitors, Vasodilators, etc.)
- Patients with the following past medical history/comorbidities at the screening visit 6.1. Uncontrolled diabetic patients with HbA1c ≥ 9% 6.2. Patients with severe heart disease (heart failure (NYHA class 3 and 4)), ischemic heart disease (unstable angina, acute myocardial infarction) within 6 months of screening, peripheral vascular disease, percutaneous coronary angioplasty or coronary artery bypass surgery ruler) 6.3. Patients with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmias determined by the investigator to be clinically significant 6.4. Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, hemodynamically significant aortic stenosis, stenosis on the aortic or mitral valve 6.5. Patients with the severe cerebrovascular disorder (stroke, cerebral infarction, cerebral hemorrhage, etc. within 6 months of screening) 6.6. Patients with known moderate or malignant retinopathy (retinal hemorrhage within 6 months of screening, visual impairment, retinal microaneurysm) 6.7. Patients with wasting disease, autoimmune disease, connective tissue disease 6.8. Patients with gastrointestinal diseases and surgeries that may affect drug absorption, distribution, metabolism, and excretion, current active gastritis, gastrointestinal/rectal bleeding, gastric ulcer, pancreatic dysfunction such as pancreatitis, active inflammatory bowel syndrome within 12 months of screening Back (However, simple appendectomy and hernia surgery are excluded) 6.9. Patients with hereditary angioedema or with a history of angioedema when treated with ACE inhibitors, renin inhibitors, or angiotensin II receptor antagonists 6.10. cholestatic disease patient 6.11. shock patient 6.12. Patients with anuria 6.13. Patients with symptomatic hyperuricemia (history of gout or uric acid stones) 6.14. Patients with a history of malignant tumors including leukemia and lymphoma within 5 years of screening (however, those who have been evaluated as having complete response after treatment and have not relapsed within 2 years of screening, or malignant tumors that have occurred are the only Those with basal cell carcinoma or squamous cell carcinoma of the skin can participate in this test) 6.15. Patients with any chronic inflammatory condition requiring chronic anti-inflammatory treatment
Show all 15Show fewer
- Persons whose laboratory test results at the screening visit fall under the following 7.1. Those whose ALT or AST levels are more than 3 times the upper limit of normal organ 7.2. Those whose serum creatinine level is 1.5 times or more of the upper limit of normal organ 7.3. Patients with renal impairment with severe renal failure with Creatinine Clearance (CrCl) < 30 mL/min or eGFR < 30 ml/min/1.73 m2 7.4. Hypokalemia (Serum K < 3.5 mmol/L) 7.5. Persons with hyperkalemia (Serum K > 5.5 mmol/L) 7.6. Those with hyponatremia (Serum Na < 135.0 mmol/L) 7.7. Those with hypercalcemia (Serum Ca > 2.75 mmol/L or 11 mg/dL)
- Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Persons with or suspected of drug or alcohol abuse
- Pregnant or lactating women
- Women and men of childbearing potential who do not agree to use a combination of effective or medically acceptable contraceptive methods* for the duration of the clinical trial and 4 weeks after administration of the last investigational drug
- Taking birth control pills or implanting hormones, implanting intrauterine devices or intrauterine systems, double-blocking methods (both male (condom) and female (contraceptive diaphragm, vaginal sponge or cervical cap) using a contraceptive device), sterilization ( vasectomy, tubal ligation, etc.)
- Persons with a history of hypersensitivity to clinical investigational drug components and other dihydropyridine drugs, thiazide drugs, or sulfonamide derivatives
- Those who participated in another clinical trial within 4 weeks before the screening visit and received the investigational drug
- Others who are judged to be unable to participate in clinical trials cording to the judgment of the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA Gangnam Medical Center, CHA University
Seoul, Gangnam, 06135
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel, Phase 2 Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension
This study purpose is to determine the appropriate combination drug dose by comparing safety and efficacy with placebo, candesartan, and amlodipine monotherapy after 8 weeks of administration of SPC1001 to patients with essential hypertension.
Read the detailed description
This clinical trial is a randomized, double-blind, parallel design, placebo and active drug comparison, and multicenter clinical trial to evaluate the safety and efficacy of investigational drugs after 8 weeks of administration.
Subjects who meet the selection and exclusion criteria should take a placebo for 2 weeks during the run-in period and run a lifestyle improvement program in parallel.
However, if you are already taking antihypertensive drugs at the time of screening, you should stop taking your existing antihypertensive drugs for at least 4 weeks from before the run-in period to the time of randomization to avoid affecting the clinical trial results.
Subjects who meet the final selection and exclusion criteria at the end of the run-in period are randomly assigned 1:1:1:1:1:1:1:1 to each administration group, receive a prescription for clinical trial drugs, and administer for 8 weeks in a double-blind manner.
Encourage the subjects to continuously perform the lifestyle improvement program for 8 weeks during the administration of the clinical investigational drug and visit the testing institution at 4 and 8 weeks during the 8-week trial period, excluding randomized visits, to check the efficacy and safety.
- Conditions
- Hypertension, Essential Hypertension
- Being tested
- SPC1001 High, SPC1001 Mid1, SPC1001 Mid2, SPC1001 Low, SPC3001
- Keywords
- SP-CAP-002
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPC1001 HighDrug
Drugs for clinical trials are orally administered once a day after breakfast.
After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
SPC1001 Mid1Drug
Drugs for clinical trials are orally administered once a day after breakfast.
After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
SPC1001 Mid2Drug
Drugs for clinical trials are orally administered once a day after breakfast.
After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
SPC1001 LowDrug
Drugs for clinical trials are orally administered once a day after breakfast.
After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
SPC3001Drug
Also called Candesartan 8mg
Drugs for clinical trials are orally administered once a day after breakfast.
After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
SPC4001Drug
Also called Amlodipine 5mg
Drugs for clinical trials are orally administered once a day after breakfast.
After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
SPC4002Drug
Also called Amlodipine 10mg
Drugs for clinical trials are orally administered once a day after breakfast.
After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
PlaceboDrug
Drugs for clinical trials are orally administered once a day after breakfast.
After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SPC1001 High | Experimental | SPC1001 High (Candesartan/Amlodipine/Indapamide) Receives: Drug: SPC1001 High; Drug: Placebo |
| SPC1001 Mid1 | Experimental | SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide) Receives: Drug: SPC1001 Mid1; Drug: Placebo |
| SPC1001 Mid2 | Experimental | SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide) Receives: Drug: SPC1001 Mid2; Drug: Placebo |
| SPC1001 Low | Experimental | SPC1001 Low (Candesartan/Amlodipine/Indapamide) Receives: Drug: SPC1001 Low; Drug: Placebo |
| SPC3001 | Active comparator | SPC3001 (Candesartan 8mg) Receives: Drug: SPC3001; Drug: Placebo |
| SPC4001 | Active comparator | SPC4001 (Amlodipine 5mg) Receives: Drug: SPC4001; Drug: Placebo |
| SPC4002 | Active comparator | SPC4002 (Amlodipine 10mg) Receives: Drug: SPC4002; Drug: Placebo |
| Placebo | Placebo comparator | SPC1001(High, Mid1, Mid2, Low) placebo, SPC3001 placebo, SPC4001 placebo, SPC4002 placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSSBP measures the amount of change after 8 weeks from baseline
MSSBP measures the amount of change after 8 weeks from baseline
Measured: 8 weeks from baseline
Secondary outcomes (4)
MSSBP measures the amount of change after 4 weeks from baseline
MSSBP measures the amount of change after 4 weeks from baseline
Measured: 4 weeks from baseline
MSDBP measures the amount of change after 4 weeks, 8 weeks from baseline
MSDBP measures the amount of change after 4 weeks, 8 weeks from baseline
Measured: 4, 8 weeks from baseline
blood pressure normalization rate
The Proportion of subjects who reached target blood pressure at 4 and 8 weeks of administration of the clinical trial drug
Measured: 4, 8 weeks from baseline
blood pressure response rate
The proportion of subjects whose MSSBP decreased by 20 mmHg or more and/or MSDBP decreased by 10 mmHg or more compared to baseline at 4 or 8 weeks after administration of the clinical trial drug
Measured: 4, 8 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start25 Mar 2022
- Primary completion27 Nov 2022
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Model description
- This clinical trial is a randomized, double-blind, parallel design, placebo and active drug comparison, and multicenter clinical trial to evaluate the safety and efficacy of investigational drugs after 8 weeks of administration.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 253 participants (actual)
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
- NCT06212648
- Sponsor's protocol ID
- SP-CAP-002
- Acronym
- SP-CAP-002
- Status last verified
- Jan 2024
- First submitted
- 14 Nov 2022
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shin J, Kim S, Han K, Kim M, Ahn Y, Sohn I, Kim K, Cha D, Hong S, Cho E, Lee H, Pyun W, Youn H, Kim W, Rhee M, Lee J, Ha J, Choi J, Yoo B, Jeong J, Chung W, Jeong Y, Kim C. Multicenter, Randomized, Double-Blind, Parallel, Phase 2 Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension. Clin Ther. 2025 Dec;47(12):1113-1123. doi: 10.1016/j.clinthera.2025.10.001. Epub 2025 Oct 28.
PubMed 41162308
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel, Phase 2 Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT06212648
- Acronym / sponsor ID
- SP-CAP-002 / SP-CAP-002
- Conditions
- Hypertension, Essential Hypertension
- Keywords
- SP-CAP-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 19 Jan 2024 (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.
This study purpose is to determine the appropriate combination drug dose by comparing safety and efficacy with placebo, candesartan, and amlodipine monotherapy after 8 weeks of administration of SPC1001 to patients with essential hypertension.
Detailed description
This clinical trial is a randomized, double-blind, parallel design, placebo and active drug comparison, and multicenter clinical trial to evaluate the safety and efficacy of investigational drugs after 8 weeks of administration.
Subjects who meet the selection and exclusion criteria should take a placebo for 2 weeks during the run-in period and run a lifestyle improvement program in parallel.
However, if you are already taking antihypertensive drugs at the time of screening, you should stop taking your existing antihypertensive drugs for at least 4 weeks from before the run-in period to the time of randomization to avoid affecting the clinical trial results.
Subjects who meet the final selection and exclusion criteria at the end of the run-in period are randomly assigned 1:1:1:1:1:1:1:1 to each administration group, receive a prescription for clinical trial drugs, and administer for 8 weeks in a double-blind manner.
Encourage the subjects to continuously perform the lifestyle improvement program for 8 weeks during the administration of the clinical investigational drug and visit the testing institution at 4 and 8 weeks during the 8-week trial period, excluding randomized visits, to check the efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
- Model description
- This clinical trial is a randomized, double-blind, parallel design, placebo and active drug comparison, and multicenter clinical trial to evaluate the safety and efficacy of investigational drugs after 8 weeks of administration.
| Arm | Type | Receives |
|---|---|---|
| SPC1001 High | Experimental | Drug: SPC1001 High, Drug: PlaceboSPC1001 High (Candesartan/Amlodipine/Indapamide) |
| SPC1001 Mid1 | Experimental | Drug: SPC1001 Mid1, Drug: PlaceboSPC1001 Mid1 (Candesartan/Amlodipine/Indapamide) |
| SPC1001 Mid2 | Experimental | Drug: SPC1001 Mid2, Drug: PlaceboSPC1001 Mid1 (Candesartan/Amlodipine/Indapamide) |
| SPC1001 Low | Experimental | Drug: SPC1001 Low, Drug: PlaceboSPC1001 Low (Candesartan/Amlodipine/Indapamide) |
| SPC3001 | Active comparator | Drug: SPC3001, Drug: PlaceboSPC3001 (Candesartan 8mg) |
| SPC4001 | Active comparator | Drug: SPC4001, Drug: PlaceboSPC4001 (Amlodipine 5mg) |
| SPC4002 | Active comparator | Drug: SPC4002, Drug: PlaceboSPC4002 (Amlodipine 10mg) |
| Placebo | Placebo comparator | Drug: PlaceboSPC1001(High, Mid1, Mid2, Low) placebo, SPC3001 placebo, SPC4001 placebo, SPC4002 placebo |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women between the ages of 19 and 75
- Those whose blood pressure measured at the time of screening meets the following criteria 2.1 Not taking antihypertensive drugs (Naïve): 140 mmHg ≤ MSSBP (mean sitting SBP) < 180 mmHg 2.2 If you are taking antihypertensive drugs or have diabetes or chronic kidney disease: 130 mmHg ≤ MSSBP < 180 mmHg
- Those whose blood pressure measured at the time of randomization meets the following criteria 3.1. 140 mmHg ≤ MSSBP < 180 mmHg 3.2. Or patients with diabetes or chronic kidney disease 130 mmHg ≤ MSSBP < 180 mmHg (However, patients with chronic kidney disease who have clinically significant albuminuria or proteinuria within 6 months)
- Those who voluntarily agreed to participate in this clinical trial and signed the consent form
Key exclusion criteria (15 listed)
- Those whose blood pressure measured at screening and randomization is MSDBP (Mean Sitting DBP) ≥ 110 mmHg
- Patients who showed a difference of SBP 20 mmHg or more and DBP 10 mmHg or more in blood pressure measured 3 times in both arms at screening
- Patients with a history of secondary hypertension or any history of suspected secondary hypertension (aortic stenosis, primary hyperaldosteronemia, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)
- Patients with symptomatic orthostatic hypotension
- Patients requiring concomitant administration of other antihypertensive drugs in addition to investigational drugs during clinical trial participation (Diuretics, β-blockers, ACE inhibitors, Angiotensin II Receptor Blocker, Calcium Channel Blockers, α-blockers, Renin Inhibitors, Vasodilators, etc.)
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 HighDrugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks. | Drug | SPC1001 High |
| SPC1001 Mid1Drugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks. | Drug | SPC1001 Mid1 |
| SPC1001 Mid2Drugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks. | Drug | SPC1001 Mid2 |
| SPC1001 LowDrugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks. | Drug | SPC1001 Low |
| SPC3001Also: Candesartan 8mgDrugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks. | Drug | SPC3001 |
| SPC4001Also: Amlodipine 5mgDrugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks. | Drug | SPC4001 |
| SPC4002Also: Amlodipine 10mgDrugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks. | Drug | SPC4002 |
| PlaceboDrugs for clinical trials are orally administered once a day after breakfast. After randomization, the drug for clinical trials is taken once a day (total of 4 tablets) for 8 weeks. | Drug | Placebo, SPC1001 High, SPC1001 Low, SPC1001 Mid1, SPC1001 Mid2, SPC3001, SPC4001, SPC4002 |
Primary outcome
MSSBP measures the amount of change after 8 weeks from baseline
Time frame: 8 weeks from baseline
MSSBP measures the amount of change after 8 weeks from baseline
4 secondary outcomes
MSSBP measures the amount of change after 4 weeks from baseline
Time frame: 4 weeks from baseline
MSDBP measures the amount of change after 4 weeks, 8 weeks from baseline
Time frame: 4, 8 weeks from baseline
blood pressure normalization rate
Time frame: 4, 8 weeks from baseline
blood pressure response rate
Time frame: 4, 8 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Derived from this study: PubMed 41162308Shin J, Kim S, Han K, Kim M, Ahn Y, Sohn I, Kim K, Cha D, Hong S, Cho E, Lee H, Pyun W, Youn H, Kim W, Rhee M, Lee J, Ha J, Choi J, Yoo B, Jeong J, Chung W, Jeong Y, Kim C. Multicenter, Randomized, Double-Blind, Parallel, Phase 2 Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension. Clin Ther. 2025 Dec;47(12):1113-1123. doi: 10.1016/j.clinthera.2025.10.001. Epub 2025 Oct 28.
- From epidemiological transition to modern cardiovascular epidemiology: hypertension in the 21st centuryLink provided by the sponsor.
- When should antihypertensive drug treatment be initiated and to what levels should systolic blood pressure be lowered? A critical reappraisalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 High, SPC1001 Mid1 and SPC1001 Mid2 in people with Hypertension and Essential Hypertension, 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 4 inclusion and 15 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 19 Jan 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. Some participants in this study may receive a placebo. 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?
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?
MSSBP measures the amount of change after 8 weeks from baseline (time frame: 8 weeks from baseline). 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 NCT06212648, 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 19 Jan 2024.