RecruitingPhase 2NCT06826872

Efficacy and Safety of SPC1001 in Patients With Essential Hypertension

A Multicenter, Randomized, Double-Blind, Parallel, Phase 2(2b) Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 in Patients With Essential Hypertension


Sponsor

Shin Poong Pharmaceutical Co. Ltd.

Enrollment

252 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 YearsMax Age: 75 Years

Inclusion Criteria1

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

Exclusion Criteria1

  • 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.

Interventions

DRUGSPC 1001 Mid2

low-dose combination therapy

DRUGSPC 2002

low-dose combination therapy

DRUGSPC 2003

low-dose combination therapy

DRUGSPC 2004

low-dose combination therapy


Locations(1)

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

Seoul, South Korea

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NCT06826872


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