Efficacy and Safety of SPC1001 in Patients With Essential Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SPC 1001 Mid2, SPC 2002, SPC 2003, SPC 2004.
- Who it may be relevant to
- Registry conditions: Hypertension, Essential, Cardiovascular Diseases, Cardiology. Basic parameters: 19 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
\- 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.
Interventions
- Drug SPC 1001 Mid2
low-dose combination therapy - Drug SPC 2002
low-dose combination therapy - Drug SPC 2003
low-dose combination therapy - Drug SPC 2004
low-dose combination therapy
Primary outcome measures
- The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8. [Time frame: Change from Baseline in MSSBP at Week 8]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea — Seoul
Identifiers
NCT: NCT06826872 · SP-CAP-HTN-202