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Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension — SP-CAP-002  

Hypertension Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06212648
Study type Interventional
Source Shin Poong Pharmaceutical Co. Ltd.
Contact
Status Completed
Phase Phase 2
Start date March 25, 2022
Completion date January 27, 2023
View Details
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