Evaluating a new combination therapy for high blood pressure
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
This study is testing a new combination of three blood pressure medications to see if it helps adults with high blood pressure better than other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | Shin Poong Pharmaceutical Co. Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06826872 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of a fixed-dose combination therapy (SPC1001) consisting of candesartan, amlodipine, and indapamide in adults with essential hypertension. Participants will be randomly assigned to receive either the triple combination therapy or dual-component therapies for a duration of 8 weeks. The study will involve multiple centers and will utilize a double-blind, parallel-group design to ensure unbiased results. Screening will occur within four weeks prior to randomization to confirm eligibility based on blood pressure measurements.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 19 to 75 years with controlled blood pressure levels.
Not a fit: Patients with severely elevated blood pressure (≥180 mmHg systolic or ≥110 mmHg diastolic) may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a more effective treatment option for patients with essential hypertension.
How similar studies have performed: Other studies have shown promise with similar combination therapies for hypertension, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: YeongJin Jeong, Master
- Email: yjjeong@shinpoong.co.kr
- Phone: +82 2-2189-3944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.