Actively Recruiting
A Multicenter, Randomized, Double-Blind, Parallel, Phase 2b Trial to Evaluate the Efficacy and Safety of SPC1001 in Adults With Essential Hypertension
Led by Shin Poong Pharmaceutical Co. Ltd. · Updated on 2025-02-14
252
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of SPC1001, a fixed-dose triple combination therapy containing candesartan, amlodipine, and indapamide, in adults with essential hypertension. This phase 2b, multicenter, randomized, double-blind trial aims to compare SPC1001 to dual-component therapies of each ingredient over an 8-week period. The study also seeks to understand the contribution of each component at low doses. Participants will be randomly assigned to receive one of several low-dose combination therapies, including SPC1001 and three other comparator treatments. Before randomization, participants will complete a 2-week run-in period taking a placebo alongside lifestyle modification. The investigational drugs will then be administered for 8 weeks to evaluate their effects. During the study, participants will have blood pressure measured regularly, including a primary assessment of mean sitting systolic blood pressure changes from baseline to week 8. Screening assessments will occur within 4 weeks before randomization to confirm eligibility. The study monitors safety and efficacy throughout the treatment period, with follow-up visits to track participant progress and outcomes.
CONDITIONS
Brief 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
- Blood pressure at screening visit meets study criteria
- Able to provide informed consent
- Willing to participate in lifestyle modification and placebo run-in period
You will not qualify if you...
- Blood pressure at screening or randomization with MSSBP 6180 mmHg or MSDBP 6110 mmHg
- Presence of other significant medical conditions as specified by the study protocol
- Any contraindications to study medications
- Participation in another clinical trial within a specified timeframe
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive one of the low-dose combination drug therapies to manage essential hypertension.
Baseline visit and follow-up visits during treatment period
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
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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