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Clinical Trial to Evaluate the Efficacy and Safety of CKD-386

A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase III Trial to Evaluate the Efficacy and Safety of D013, D326 and D337 Combination Therapy in Dyslipidemia Patients With Hypertension

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04312698
Enrollment
100
Registered
2020-03-18
Start date
2019-08-29
Completion date
2021-06-18
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia Patients With Hypertension

Brief summary

Clinical Trial to Evaluate the Efficacy and Safety of CKD-386

Interventions

Experimental: Group 1 Patients assigned to this group are treated with D013, D326, D337

DRUGplacebo of D013, D326, D337

Placebo Comparator: Group 1 Patients assigned to this group are treated with D326, D337, placebo of D013

DRUGD013, placebo of D326, placebo of D337

Placebo Comparator: Group 2 Patients assigned to this group are treated with D013, placebo of D326, placebo of D337

Sponsors

Chong Kun Dang Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Subjects are diagnosed with Dyslipidemia Patients with Hypertension or are being administered anti-hypertension and anti-hypertension drugs after diagnosis. 2. Subjects who agreed to participate in this clinical trial voluntarily.

Exclusion criteria

1. Subjects who were satisfied specific blood pressure levels that measured at screening period. 2. Subjects who were satisfied specific lipid levels that measured at screening period. 3. Subjects who cannot participate in a clinical trial based on the PI's judgment.

Design outcomes

Primary

MeasureTime frameDescription
Change rate from baseline in LDL-C8 weeks after drug administrationsCompare experimental group 1 with comparator group 1
Change from baseline in MSSBP8 weeks after drug administrationsCompare experimental group 1 with comparator group 2

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026