Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension
Condition: Hypertension; Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): SPC1001 High; SPC1001 Mid1; SPC1001 Mid2; SPC1001 Low; SPC3001; SPC4001; SPC4002; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.; 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.; 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.; 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.; 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.; 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.; 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.
Other intervention name(s): Candesartan 8mg; Amlodipine 5mg; Amlodipine 10mg
Intervention MeSH terms: Amlodipine; Candesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model 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.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SP-CAP-002