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Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy

A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R208 and Each Monotherapy in Patients With Hypertension and Primary Hypercholesterolemia.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02770261
Enrollment
219
Registered
2016-05-12
Start date
2015-12-31
Completion date
2016-10-31
Last updated
2016-12-26

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

Conditions

Hypertension, Cholesterolemia

Keywords

DP-R208

Brief summary

The purpose of this study is to determine superiority of DP-R208 compare to each monotherapy in patient with hypertension and primary hypercholesterolemia.

Interventions

DRUGDP-R208

DP-R208 + Candesartan 32mg placebo + Rosuvastatin 20mg placebo

DRUGCandesartan32mg

DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo

DRUGRosuvastatin 20mg

DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

DRUGDP-R208 Placebo

DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

DRUGCandesartan32mg Placebo

DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

DRUGRosuvastatin 20mg Placebo

DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo

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 19years old. * Hypertension with primary cholesterolemia and satisfy the lab results that Mean msSBP is under 180mmHg and Mean msDBP is under 110mmHg and LDL-C is 250mg/DL or under and Triglycerides is under 400mg/dL

Exclusion criteria

* Therapeutic lifestylechange is not enought during the study period * SBP difference is bigger than 20mmHg or DBP difference is bigger than 10mmHg at screening visit

Design outcomes

Primary

MeasureTime frame
Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol8weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026