Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension

NCT06212648 | Completed Phase 2

• 1 other identifier: SP-CAP-002
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Essential Hypertension

Keywords

SP-CAP-002

Outcome Measures

Primary Outcomes (1)

• MSSBP measures the amount of change after 8 weeks from baseline

  MSSBP measures the amount of change after 8 weeks from baseline

  8 weeks from baseline

Secondary Outcomes (4)

• MSSBP measures the amount of change after 4 weeks from baseline

  4 weeks from baseline

• MSDBP measures the amount of change after 4 weeks, 8 weeks from baseline

  4, 8 weeks from baseline

• blood pressure normalization rate

  4, 8 weeks from baseline

• blood pressure response rate

  4, 8 weeks from baseline

Study Arms (8)

SPC1001 High

EXPERIMENTAL

SPC1001 High (Candesartan/Amlodipine/Indapamide)

Drug: SPC1001 High; Drug: Placebo

SPC1001 Mid1

EXPERIMENTAL

SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide)

Drug: SPC1001 Mid1; Drug: Placebo

SPC1001 Mid2

EXPERIMENTAL

SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide)

Drug: SPC1001 Mid2; Drug: Placebo

SPC1001 Low

EXPERIMENTAL

SPC1001 Low (Candesartan/Amlodipine/Indapamide)

Drug: SPC1001 Low; Drug: Placebo

SPC3001

ACTIVE COMPARATOR

SPC3001 (Candesartan 8mg)

Drug: SPC3001; Drug: Placebo

SPC4001

ACTIVE COMPARATOR

SPC4001 (Amlodipine 5mg)

Drug: SPC4001; Drug: Placebo

SPC4002

ACTIVE COMPARATOR

SPC4002 (Amlodipine 10mg)

Drug: SPC4002; Drug: Placebo

Placebo

PLACEBO COMPARATOR

SPC1001(High, Mid1, Mid2, Low) placebo, SPC3001 placebo, SPC4001 placebo, SPC4002 placebo

Drug: Placebo

Interventions

SPC1001 High DRUG

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 High

SPC1001 Mid1 DRUG

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 Mid1

SPC1001 Mid2 DRUG

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 Mid2

SPC1001 Low DRUG

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 Low

SPC3001 DRUG

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.

Also known as: Candesartan 8mg

SPC3001

SPC4001 DRUG

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.

Also known as: Amlodipine 5mg

SPC4001

SPC4002 DRUG

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.

Also known as: Amlodipine 10mg

SPC4002

Placebo DRUG

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.

Placebo; SPC1001 High; SPC1001 Low; SPC1001 Mid1; SPC1001 Mid2; SPC3001; SPC4001; SPC4002

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (1)

CHA Gangnam Medical Center, CHA University

Seoul, Gangnam, 06135, South Korea

Location

Related Publications (1)

• 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.

  PMID: 41162308 DERIVED

Related Links

• From epidemiological transition to modern cardiovascular epidemiology: hypertension in the 21st century
• When should antihypertensive drug treatment be initiated and to what levels should systolic blood pressure be lowered? A critical reappraisal

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

candesartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: January 19, 2024
• Study Start: March 25, 2022
• Primary Completion: November 27, 2022
• Study Completion: January 27, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)