Efficacy and Safety of SPC1001 in Patients With Essential Hypertension
NCT ID: NCT06826872
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
252 participants
INTERVENTIONAL
2024-06-12
2025-12-30
Brief Summary
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\- 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SPC 1001 Mid2
SPC 1001 Mid2
low-dose combination therapy
SPC2002
SPC 1001 Mid2
low-dose combination therapy
SPC 2002
low-dose combination therapy
SPC2003
SPC 1001 Mid2
low-dose combination therapy
SPC 2003
low-dose combination therapy
SPC2004
SPC 1001 Mid2
low-dose combination therapy
SPC 2004
low-dose combination therapy
Interventions
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SPC 1001 Mid2
low-dose combination therapy
SPC 2002
low-dose combination therapy
SPC 2003
low-dose combination therapy
SPC 2004
low-dose combination therapy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
75 Years
ALL
No
Sponsors
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Shin Poong Pharmaceutical Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SP-CAP-HTN-202
Identifier Type: -
Identifier Source: org_study_id
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