Efficacy and Safety of SPC1001 in Patients With Essential Hypertension

Recruiting now · Phase 2

Conditions studied: Hypertension, Essential, Cardiovascular Diseases, Cardiology

In brief

\- 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.

Key facts

Study ID

NCT06826872

Run by

Shin Poong Pharmaceutical Co. Ltd.

People needed

252

Starts

2024-06-12

Expected to finish

2025-12-30

Last updated by the study team

2025-02-14

Who can join

Age: 19 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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