Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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