Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension (SP-CAP-002)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Essential Hypertension
• Intervention / Treatment: Drug: SPC1001 High; Drug: Placebo; Drug: SPC1001 Mid1; Drug: SPC1001 Mid2; Drug: SPC1001 Low; Drug: SPC3001; Drug: SPC4001; Drug: SPC4002

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 Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam
    • Seoul, Gangnam, Korea, Republic of, 06135
      • CHA Gangnam Medical Center, CHA University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men and women between the ages of 19 and 75
2. 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
3. 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)
4. Those who voluntarily agreed to participate in this clinical trial and signed the consent form

Exclusion Criteria:

1. Those whose blood pressure measured at screening and randomization is MSDBP (Mean Sitting DBP) ≥ 110 mmHg
2. 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
3. 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.)
4. Patients with symptomatic orthostatic hypotension
5. 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.)
6. 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
7. 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)
8. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
9. Persons with or suspected of drug or alcohol abuse
10. Pregnant or lactating women

11. 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.)

12. Persons with a history of hypersensitivity to clinical investigational drug components and other dihydropyridine drugs, thiazide drugs, or sulfonamide derivatives
13. Those who participated in another clinical trial within 4 weeks before the screening visit and received the investigational drug
14. Others who are judged to be unable to participate in clinical trials cording to the judgment of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPC1001 High; SPC1001 High (Candesartan/Amlodipine/Indapamide)	Drug: SPC1001 High; 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.; Drug: Placebo; 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.
Experimental: SPC1001 Mid1; SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide)	Drug: Placebo; 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.; Drug: SPC1001 Mid1; 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.
Experimental: SPC1001 Mid2; SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide)	Drug: Placebo; 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.; Drug: SPC1001 Mid2; 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.
Experimental: SPC1001 Low; SPC1001 Low (Candesartan/Amlodipine/Indapamide)	Drug: Placebo; 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.; Drug: SPC1001 Low; 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.
Active Comparator: SPC3001; SPC3001 (Candesartan 8mg)	Drug: Placebo; 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.; Drug: SPC3001; 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.; Other Names: Candesartan 8mg
Active Comparator: SPC4001; SPC4001 (Amlodipine 5mg)	Drug: Placebo; 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.; Drug: SPC4001; 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.; Other Names: Amlodipine 5mg
Active Comparator: SPC4002; SPC4002 (Amlodipine 10mg)	Drug: Placebo; 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.; Drug: SPC4002; 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.; Other Names: Amlodipine 10mg
Placebo Comparator: Placebo; SPC1001(High, Mid1, Mid2, Low) placebo, SPC3001 placebo, SPC4001 placebo, SPC4002 placebo	Drug: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MSSBP measures the amount of change after 4 weeks from baseline	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	MSDBP measures the amount of change after 4 weeks, 8 weeks from baseline	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	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	4, 8 weeks from baseline

Collaborators and Investigators

• Sponsor: Shin Poong Pharmaceutical Co. Ltd.

Publications and helpful links

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2022
• Primary Completion (Actual): November 27, 2022
• Study Completion (Actual): January 27, 2023

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: SP-CAP-002
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Candesartan
• Other Study ID Numbers: SP-CAP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No