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
Overview
- Phase
- Phase 2
- Intervention
- SPC1001 High
- Conditions
- Hypertension
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Enrollment
- 253
- Locations
- 1
- Primary Endpoint
- MSSBP measures the amount of change after 8 weeks from baseline
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
SPC1001 High
SPC1001 High (Candesartan/Amlodipine/Indapamide)
Intervention: SPC1001 High
SPC1001 High
SPC1001 High (Candesartan/Amlodipine/Indapamide)
Intervention: Placebo
SPC1001 Mid1
SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide)
Intervention: SPC1001 Mid1
SPC1001 Mid1
SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide)
Intervention: Placebo
SPC1001 Mid2
SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide)
Intervention: SPC1001 Mid2
SPC1001 Mid2
SPC1001 Mid1 (Candesartan/Amlodipine/Indapamide)
Intervention: Placebo
SPC1001 Low
SPC1001 Low (Candesartan/Amlodipine/Indapamide)
Intervention: SPC1001 Low
SPC1001 Low
SPC1001 Low (Candesartan/Amlodipine/Indapamide)
Intervention: Placebo
SPC3001
SPC3001 (Candesartan 8mg)
Intervention: SPC3001
SPC3001
SPC3001 (Candesartan 8mg)
Intervention: Placebo
SPC4001
SPC4001 (Amlodipine 5mg)
Intervention: SPC4001
SPC4001
SPC4001 (Amlodipine 5mg)
Intervention: Placebo
SPC4002
SPC4002 (Amlodipine 10mg)
Intervention: SPC4002
SPC4002
SPC4002 (Amlodipine 10mg)
Intervention: Placebo
Placebo
SPC1001(High, Mid1, Mid2, Low) placebo, SPC3001 placebo, SPC4001 placebo, SPC4002 placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)