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To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension

A Multi-center, Randomized, Double-blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients With Dyslipidemia and Hypertension.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05331014
Enrollment
155
Registered
2022-04-15
Start date
2021-11-15
Completion date
2022-11-08
Last updated
2024-03-15

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

Conditions

Dyslipidemia, Hypertension

Brief summary

A Multi-center, Randomized, Double-blind, Parallel, phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients with Dyslipidemia and Hypertension.

Detailed description

Multicenter, randomized, double-blind, parallel-design, phase III clinical study

Interventions

For 8 weeks(PO, QD)

For 8 weeks(PO, QD)

DRUGVA

For 8 weeks(PO, QD)

Sponsors

JW Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Patients with hypertension and dyslipidemia

Exclusion criteria

* The subject not meet the specified msBP and LDL-C level

Design outcomes

Primary

MeasureTime frameDescription
msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effectweek 8change in msSBP and LDL-C level

Secondary

MeasureTime frameDescription
efficacy and safetyweek 8change in msSBP and LDL-C level

Countries

South Korea

Outcome results

None listed

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