Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06212648
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2022-11-14
Brief Title:
Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension
Sponsor:
Shin Poong Pharmaceutical Co Ltd
Organization:
Shin Poong Pharmaceutical Co Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SP-CAP-002
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 11111111 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
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 11111111 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None