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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- MSSBP measures the amount of change after 8 weeks from baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •140 mmHg ≤ MSSBP < 180 mmHg 3.
- •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
排除标准
- •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.
- •Uncontrolled diabetic patients with HbA1c ≥ 9% 6.
- •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.
- •Patients with clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmias determined by the investigator to be clinically significant 6.
- •Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, hemodynamically significant aortic stenosis, stenosis on the aortic or mitral valve 6.
- •Patients with the severe cerebrovascular disorder (stroke, cerebral infarction, cerebral hemorrhage, etc. within 6 months of screening) 6.
- •Patients with known moderate or malignant retinopathy (retinal hemorrhage within 6 months of screening, visual impairment, retinal microaneurysm) 6.
- •Patients with wasting disease, autoimmune disease, connective tissue disease 6.
- •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.
- •Patients with hereditary angioedema or with a history of angioedema when treated with ACE inhibitors, renin inhibitors, or angiotensin II receptor antagonists 6.
- •cholestatic disease patient 6.
- •shock patient 6.
- •Patients with anuria 6.
- •Patients with symptomatic hyperuricemia (history of gout or uric acid stones) 6.
- •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.
- •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.
- •Those whose ALT or AST levels are more than 3 times the upper limit of normal organ 7.
- •Those whose serum creatinine level is 1.5 times or more of the upper limit of normal organ 7.
- •Patients with renal impairment with severe renal failure with Creatinine Clearance (CrCl) < 30 mL/min or eGFR < 30 ml/min/1.73 m2 7.
- •Hypokalemia (Serum K < 3.5 mmol/L) 7.
- •Persons with hyperkalemia (Serum K > 5.5 mmol/L) 7.
- •Those with hyponatremia (Serum Na < 135.0 mmol/L) 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
研究组 & 干预措施
SPC1001 High
SPC1001 High (Candesartan/Amlodipine/Indapamide)
干预措施: SPC1001 High (Drug)
SPC1001 High
SPC1001 High (Candesartan/Amlodipine/Indapamide)
干预措施: Placebo (Drug)
SPC1001 Mid1
SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide)
干预措施: SPC1001 Mid1 (Drug)
SPC1001 Mid1
SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide)
干预措施: Placebo (Drug)
SPC1001 Mid2
SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide)
干预措施: SPC1001 Mid2 (Drug)
SPC1001 Mid2
SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide)
干预措施: Placebo (Drug)
SPC1001 Low
SPC1001 Low (Candesartan/Amlodipine/Indapamide)
干预措施: SPC1001 Low (Drug)
SPC1001 Low
SPC1001 Low (Candesartan/Amlodipine/Indapamide)
干预措施: Placebo (Drug)
SPC3001
SPC3001 (Candesartan 8mg)
干预措施: SPC3001 (Drug)
SPC3001
SPC3001 (Candesartan 8mg)
干预措施: Placebo (Drug)
SPC4001
SPC4001 (Amlodipine 5mg)
干预措施: SPC4001 (Drug)
SPC4001
SPC4001 (Amlodipine 5mg)
干预措施: Placebo (Drug)
SPC4002
SPC4002 (Amlodipine 10mg)
干预措施: SPC4002 (Drug)
SPC4002
SPC4002 (Amlodipine 10mg)
干预措施: Placebo (Drug)
Placebo
SPC1001(High, Mid1, Mid2, Low) placebo, SPC3001 placebo, SPC4001 placebo, SPC4002 placebo
干预措施: Placebo (Drug)
结局指标
主要结局
MSSBP measures the amount of change after 8 weeks from baseline
时间窗: 8 weeks from baseline
MSSBP measures the amount of change after 8 weeks from baseline
次要结局
- 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)