NCT07064525

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

A Multi-center, Randomized, Double-blind, Parallel, Phase 2b Study to Evaluate the Efficacy and Safety of SPC1001 Low in Patients With Essential Hypertension

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Shin Poong Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension (HTN)
• NYHA Class III Heart Failure
• NYHA Class IV Heart Failure
• Diabete Mellitus

Interventions

Type	Name	Description
DRUG	SPC1001 Low	low-dose combination therapy
DRUG	SPC5002	low-dose combination therapy
DRUG	SPC5003	low-dose combination therapy
DRUG	SPC5004	low-dose combination therapy

Timeline

• Start date: 2024-12-05
• Primary completion: 2025-12-15
• Completion: 2026-02-28
• First posted: 2025-07-14
• Last updated: 2025-07-14

Locations

1 site across 1 country: South Korea