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

NCT06212648 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2024-01-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Shin Poong Pharmaceutical Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2022-11-27
Completion
2023-01-27

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06212648 on ClinicalTrials.gov