Clinical trial NCT06212648: Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Essential Hypertension
Keywords: SP-CAP-002
Lead sponsor: Shin Poong Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-19
Enrollment: 253
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: MSSBP measures the amount of change after 8 weeks from baseline
timeFrame: 8 weeks from baseline
Secondary outcomes:
measure: MSSBP measures the amount of change after 4 weeks from baseline
timeFrame: 4 weeks from baseline
measure: MSDBP measures the amount of change after 4 weeks, 8 weeks from baseline
timeFrame: 4, 8 weeks from baseline
measure: blood pressure normalization rate
timeFrame: 4, 8 weeks from baseline
measure: blood pressure response rate
timeFrame: 4, 8 weeks from baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Medical Center, CHA University
state: Gangnam
Study officials:
References: