Evaluate the Efficacy and Safety of SPC1001 Low 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: SPC1001 Low, SPC5002, SPC5003, SPC5004.
- Who it may be relevant to
- Registry conditions: Hypertension (HTN), NYHA Class III Heart Failure, NYHA Class IV Heart Failure, Diabete Mellitus. 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 →
Unsure about the terms? Read our patient guide →
Official title
A Multi-center, Randomized, Double-blind, Parallel, Phase 2b Study to Evaluate the Efficacy and Safety of SPC1001 Low in Patients With Essential Hypertension
Overview
\- 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.
Interventions
- Drug SPC1001 Low
low-dose combination therapy - Drug SPC5002
low-dose combination therapy - Drug SPC5003
low-dose combination therapy - Drug SPC5004
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 in MSSBP from baseline 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
Identifiers
NCT: NCT07064525 · SP-CAP-HTN-203