NCT06826872 Efficacy and Safety of SPC1001 in Patients With Essential Hypertension
| NCT ID | NCT06826872 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shin Poong Pharmaceutical Co. Ltd. |
| Condition | Hypertension, Essential |
| Study Type | INTERVENTIONAL |
| Enrollment | 252 participants |
| Start Date | 2024-06-12 |
| Primary Completion | 2025-10-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 252 participants in total. It began in 2024-06-12 with a primary completion date of 2025-10-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06826872 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 75 Years, studying Hypertension, Essential. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06826872 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06826872 currently recruiting?
Yes, NCT06826872 is actively recruiting participants. Contact the research team at yjjeong@shinpoong.co.kr for enrollment information.
Where is the NCT06826872 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06826872 clinical trial?
NCT06826872 is sponsored by Shin Poong Pharmaceutical Co. Ltd.. The trial plans to enroll 252 participants.