A Phase 2 interventional study of SPC1001 Low and SPC5002 in Hypertension (HTN), NYHA Class III Heart Failure and NYHA Class IV Heart Failure, sponsored by Shin Poong Pharmaceutical Co. Ltd.. Enrolling by invitation at 1 site in South Korea. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by Shin Poong Pharmaceutical Co. Ltd. · Phase 2, Interventional, and Treatment
- Objective: This study aims to evaluate the safety and efficacy of the fixed-dose triple combination therapy (SPC1001 Low) 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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 252 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Shin Poong Pharmaceutical Co. Ltd. is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
low-dose combination therapy
Drug: SPC1001 Low
low-dose combination therapy
Drug: SPC1001 Low · Drug: SPC5002
low-dose combination therapy
Drug: SPC1001 Low · Drug: SPC5003
low-dose combination therapy
Drug: SPC1001 Low · Drug: SPC5004
low-dose combination therapy
low-dose combination therapy
low-dose combination therapy
low-dose combination therapy
The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8
Time frame: change in MSSBP from baseline at week 8
Plan to share: Yes — It is planned to be publicly available in the form of a future journal submission
Supporting information: Study protocol
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