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Clinical Trial to Evaluate the Efficacy and Safety of DP-R212

A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R212 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02955368
Enrollment
0
Registered
2016-11-04
Start date
2017-02-28
Completion date
2017-08-31
Last updated
2017-06-05

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

Conditions

Hypercholesterolemia, Hypertension

Keywords

DP-R212

Brief summary

The purpose of this study is to determine superiority of DP-R212 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.

Interventions

DP-R212 + C1-R212 placebo + C2-R212 placebo

DRUGC1-R212

DP-R212 placebo + C1-R212 + C2-R212 placebo

DRUGC2-R212

DP-R212 placebo + C1-R212 placebo + C2-R212

Sponsors

Alvogen Korea
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

* Both man and woman who is over 19 years old * Hypertension patient with hypercholesterolemia

Exclusion criteria

* sSBP difference is ≥20mmHg or sDBP difference is ≥10mmHg * A history of cardiovascular disease * rhabdomyolysis, myopathy * Hypertension or hypercholesterolemia due to secondary causes * Uncontrolled diabetes * Evidence of hepatic or renal disease

Design outcomes

Primary

MeasureTime frame
Percent change of LDL-Cholesterol0, 8 weeks
Change of mean seated Systolic Blood Pressure0, 8 weeks

Outcome results

None listed

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