Efficacy and Safety of SPC1001 in Patients With Essential Hypertension

NCT ID: NCT06826872

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-12

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

\- Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001) of candesartan, amlodipine, and indapamide in adult patients with essential hypertension compared to dual-component therapies of each ingredient for 8 weeks. Additionally, it seeks to confirm the contribution of each component at low doses.

\- Inclusion Criteria: Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.

\- Exclusion Criteria: Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.

\- Methods: This study is a multicenter, randomized, double-blind, parallel-group, phase 2b clinical trial to evaluate the safety and efficacy of the investigational drug after 8 weeks of administration.

Screening assessments will be conducted within 4 weeks prior to randomization, and patients who meet the inclusion and exclusion criteria at the screening visit will be enrolled in the study after providing informed consent. These participants will undergo a 2-week run-in period during which they will take a placebo and participate in a lifestyle modification program.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension, Essential Cardiovascular Diseases Cardiology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-Blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SPC 1001 Mid2

Group Type ACTIVE_COMPARATOR

SPC 1001 Mid2

Intervention Type DRUG

low-dose combination therapy

SPC2002

Group Type ACTIVE_COMPARATOR

SPC 1001 Mid2

Intervention Type DRUG

low-dose combination therapy

SPC 2002

Intervention Type DRUG

low-dose combination therapy

SPC2003

Group Type ACTIVE_COMPARATOR

SPC 1001 Mid2

Intervention Type DRUG

low-dose combination therapy

SPC 2003

Intervention Type DRUG

low-dose combination therapy

SPC2004

Group Type ACTIVE_COMPARATOR

SPC 1001 Mid2

Intervention Type DRUG

low-dose combination therapy

SPC 2004

Intervention Type DRUG

low-dose combination therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SPC 1001 Mid2

low-dose combination therapy

Intervention Type DRUG

SPC 2002

low-dose combination therapy

Intervention Type DRUG

SPC 2003

low-dose combination therapy

Intervention Type DRUG

SPC 2004

low-dose combination therapy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.

Exclusion Criteria

* Patients whose blood pressure measured at the screening and randomization visits meets the criteria of MSSBP ≥180 mmHg or MSDBP ≥110 mmHg, among other conditions.
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shin Poong Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

YeongJin Jeong, Master

Role: CONTACT

+82 2-2189-3944

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ChongJin Kim, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SP-CAP-HTN-202

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.