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

Not Applicable

• Conditions: Hypertension (HTN); NYHA Class III Heart Failure; NYHA Class IV Heart Failure; Diabete Mellitus
• Interventions: Drug: SPC1001 Low; Drug: SPC5002; Drug: SPC5003; Drug: SPC5004

• Registration Number: NCT07064525
• Lead Sponsor: Shin Poong Pharmaceutical Co. Ltd.

Brief Summary

- Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001 Low) 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

Not available

Study Timeline

• Study Start: 2024-12-05
• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Primary Completion: 2025-12-15
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 252

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPC1001 Low	SPC1001 Low	low-dose combination therapy
SPC5002	SPC1001 Low	low-dose combination therapy
SPC5002	SPC5002	low-dose combination therapy
SPC5003	SPC1001 Low	low-dose combination therapy
SPC5003	SPC5003	low-dose combination therapy
SPC5004	SPC1001 Low	low-dose combination therapy
SPC5004	SPC5004	low-dose combination therapy

Primary Outcome Measures

Name	Time	Method
The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8	change in MSSBP from baseline at week 8

Trial Locations

Locations (1)

CHA Gangnam Medical Center, CHA University; 🇰🇷 Seoul, Korea, Republic of