Actively Recruiting

Phase 2
Age: 19Years - 75Years
All Genders
NCT06826872

Efficacy and Safety of SPC1001 in Patients With Essential Hypertension

Led by Shin Poong Pharmaceutical Co. Ltd. · Updated on 2025-02-14

252

Participants Needed

1

Research Sites

80 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

\- 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

Official Title

Efficacy and Safety of SPC1001 in Patients With Essential Hypertension

Who Can Participate

Age: 19Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the study criteria
Not Eligible

You will not qualify if you...

  • Patients with sitting systolic blood pressure 180 mmHg or higher at screening or randomization
  • Patients with sitting diastolic blood pressure 110 mmHg or higher at screening or randomization
  • Other unspecified exclusion conditions as detailed in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea

Seoul, South Korea, 06135

Actively Recruiting

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Research Team

Y

YeongJin Jeong, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Efficacy and Safety of SPC1001 in Patients With Essential Hypertension | DecenTrialz