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OpenTrials
Enrolling by Invitation

NCT Number: NCT07064525

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

- 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.

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Key information

Conditions

Hypertension (HTN) Cardiovascular Diseases Diabete Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases NYHA Class III Heart Failure NYHA Class IV Heart Failure Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHA Gangnam Medical Center, CHA University

Seoul, 06135, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPC1001 Low

Drug

low-dose combination therapy

SPC5002

Drug

low-dose combination therapy

SPC5003

Drug

low-dose combination therapy

SPC5004

Drug

low-dose combination therapy

Primary outcomes

  1. The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8

    Time frame: change in MSSBP from baseline at week 8

Sponsors and collaborators

Lead sponsor

Shin Poong Pharmaceutical Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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