Efficacy and Safety of SPC1001 in Patients With Essential Hypertension
\- 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 con
| Condition(s) | Hypertension, Essential, Cardiovascular Diseases, Cardiology |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 ev |
| Who can participate | 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. |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Lead sponsor | Shin Poong Pharmaceutical Co. Ltd. |
| Locations | Seoul, South Korea |
| Start date | 2024-06-12 |
| NCT ID | NCT06826872 |
| Official listing | https://clinicaltrials.gov/study/NCT06826872 |