Evaluate the Efficacy and Safety of SPC1001 Low in Patients With Essential Hypertension

Shin Poong Pharmaceutical

Status and phase: Invitation-only; Phase 2

Conditions: Diabete Mellitus; NYHA Class IV Heart Failure; NYHA Class III Heart Failure; Hypertension (HTN)

Treatments: Drug: SPC1001 Low; Drug: SPC5002; Drug: SPC5003; Drug: SPC5004

Study type: Interventional

Funder types: Industry

Identifiers

NCT07064525

SP-CAP-HTN-203

Details and patient eligibility

About

• 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.

Enrollment: 252 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 4 patient groups

SPC1001 Low

Active Comparator group

Description:

low-dose combination therapy

Treatment:

Drug: SPC1001 Low

SPC5002

Active Comparator group

Description:

low-dose combination therapy

Treatment:

Drug: SPC5002

Drug: SPC1001 Low

SPC5003

Active Comparator group

Description:

low-dose combination therapy

Treatment:

Drug: SPC5003

Drug: SPC1001 Low

SPC5004

Active Comparator group

Description:

low-dose combination therapy

Treatment:

Drug: SPC5004

Drug: SPC1001 Low