Diabete Mellitus, Hypertension (HTN), NYHA Class III Heart Failure, NYHA Class IV Heart Failure
Conditions
Keywords
blood pressure, phase 2b, low dose combination therapy, candesartan, amlodipine, indapamide
Brief summary
\- 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
DRUGSPC1001 Low
low-dose combination therapy
DRUGSPC5002
low-dose combination therapy
DRUGSPC5003
low-dose combination therapy
DRUGSPC5004
low-dose combination therapy
Sponsors
Shin Poong Pharmaceutical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blinded
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was determined by evaluating how mean sitting systolic blood pressure varied between the baseline measurement and week 8 | change in MSSBP from baseline at week 8 |
Countries
South Korea
Outcome results
None listed