Efficacy and Safety of SPC1001 in Patients With Essential Hypertension

NCT06826872 | Recruiting Phase 2 DMC

• 1 other identifier: SP-CAP-HTN-202
• 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) 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, Essential; Cardiovascular Diseases; Cardiology

Keywords

blood pressure; 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 from Baseline in MSSBP at Week 8

Study Arms (4)

SPC 1001 Mid2

ACTIVE COMPARATOR

Drug: SPC 1001 Mid2

SPC2002

ACTIVE COMPARATOR

Drug: SPC 1001 Mid2; Drug: SPC 2002

SPC2003

ACTIVE COMPARATOR

Drug: SPC 1001 Mid2; Drug: SPC 2003

SPC2004

ACTIVE COMPARATOR

Drug: SPC 1001 Mid2; Drug: SPC 2004

Interventions

SPC 1001 Mid2 DRUG

low-dose combination therapy

SPC 1001 Mid2; SPC2002; SPC2003; SPC2004

SPC 2002 DRUG

low-dose combination therapy

SPC2002

SPC 2003 DRUG

low-dose combination therapy

SPC2003

SPC 2004 DRUG

low-dose combination therapy

SPC2004

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, Republic of Korea

Seoul, 06135, South Korea

RECRUITING

MeSH Terms

Conditions

Essential Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases

Central Study Contacts

YeongJin Jeong, Master

CONTACT

+82 2-2189-3944; yjjeong@shinpoong.co.kr

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: February 10, 2025
• First Posted: February 14, 2025
• Study Start: June 12, 2024
• Primary Completion: October 8, 2025
• Study Completion: December 30, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

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

Locations

KR (1)