NCT06212648

Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Shin Poong Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Essential Hypertension

Interventions

Type	Name	Description
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	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.
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.
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.
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.
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.
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.
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.

Timeline

• Start date: 2022-03-25
• Primary completion: 2022-11-27
• Completion: 2023-01-27
• First posted: 2024-01-19
• Last updated: 2024-01-19

Locations

1 site across 1 country: South Korea