Efficacy and Safety of SPC1001 in Patients With Essential Hypertension
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-75
SponsorShin Poong Pharmaceutical Co. Ltd.
About this trial
\- 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women aged 19 to 75 years whose blood pressure measured at the screening visit meets the following criteria.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
SPC 1001 Mid2
Druglow-dose combination therapy
SPC 2002
Druglow-dose combination therapy
SPC 2003
Druglow-dose combination therapy
SPC 2004
Druglow-dose combination therapy
Treatment groups
252 Participants
are divided into 4 treatment groupsGroup A: SPC 1001 Mid2Active comparator 1 intervention
Group B: SPC2002Active comparator 2 interventions
Group C: SPC2003Active comparator 2 interventions
Group D: SPC2004Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
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 8Sponsors and contacts
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Source ClinicalTrials.gov