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

NCT07064525 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: SP-CAP-HTN-203
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

blood pressure; phase 2b; low dose combination therapy; candesartan; amlodipine; indapamide

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

SPC1001 Low

ACTIVE COMPARATOR

low-dose combination therapy

Drug: SPC1001 Low

SPC5002

ACTIVE COMPARATOR

low-dose combination therapy

Drug: SPC1001 Low; Drug: SPC5002

SPC5003

ACTIVE COMPARATOR

low-dose combination therapy

Drug: SPC1001 Low; Drug: SPC5003

SPC5004

ACTIVE COMPARATOR

low-dose combination therapy

Drug: SPC1001 Low; Drug: SPC5004

Interventions

SPC1001 Low DRUG

low-dose combination therapy

SPC1001 Low; SPC5002; SPC5003; SPC5004

SPC5002 DRUG

low-dose combination therapy

SPC5002

SPC5003 DRUG

low-dose combination therapy

SPC5003

SPC5004 DRUG

low-dose combination therapy

SPC5004

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (1)

CHA Gangnam Medical Center, CHA University

Seoul, 06135, South Korea

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Interventions

SPC 5002

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 14, 2025
• Study Start: December 5, 2024
• Primary Completion: December 15, 2025
• Study Completion: February 28, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

KR (1)