Clinical Trial to Evaluate the Efficacy and Safety of CKD-333 Tablet

Chong Kun Dang

Status and phase: Completed; Phase 3

Conditions: Hypertensive Patients With Dyslipidemia

Treatments: Drug: Placebo of D086; Drug: Placebo of D723; Drug: D086; Drug: D723; Drug: CKD-330; Drug: Placebo of CKD-330

Study type: Interventional

Funder types: Industry

Identifiers

NCT03583905

170HT/DL17007

Details and patient eligibility

About

To Evaluate the Efficacy and Safety of CKD-333

Full description

A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-330 and D086 Combination Therapy in Hypertensive Patients with Dyslipidemia

Enrollment: 154 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with a mean sitting systolic blood pressure (MSSBP) ≥ 140 mmHg measured on selected arms after run-in period

2. Lipid levels measured after run-in period were:

   • Group 1: hypertension + dyslipidemia only → fasting LDL-C ≥ 160 mg / dL
   • Group 2: hypertension + dyslipidemia + cardiovascular risk factor more than 1 → fasting LDL-C ≥ 130mg / dL
   • Group 3: hypertension + dyslipidemia + coronary artery disease or equivalent or 10-year risk assessed by Framingham Point Score greater than 20% → fasting LDL-C ≥ 100 mg / dL

Exclusion criteria

1. Patients whose blood pressures measured at Visit 2 were:

   • Patients with MSSBP ≥ 180 mmHg and / or MSDBP ≥ 110 mmHg

2. Patients who had lipid levels measured at Visit 2

   • Patients with fasting LDL-C <100 mg / dL or fasting LDL-C> 250 mg / dL and / or TG ≥ 500 mg / dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 3 patient groups, including a placebo group

Experimental Group 1

Experimental group

Description:

Patients assigned to this group are treated with CKD-330, D086

Treatment:

Drug: Placebo of D723

Drug: CKD-330

Drug: D086

Placebo Group 1

Placebo Comparator group

Description:

Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the D086)

Treatment:

Drug: Placebo of D723

Drug: CKD-330

Drug: Placebo of D086

Placebo Group 2

Placebo Comparator group

Description:

Patients assigned to this group are treated with 1 Placebo Tab.(Placebo of the CKD-330)

Treatment:

Drug: D723

Drug: Placebo of CKD-330

Drug: D086