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CompletedNCT02770261Updated Dec 26, 2016

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

A Phase 3 interventional study of DP-R208 and Candesartan32mg in Hypertension and Cholesterolemia, sponsored by Alvogen Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2016-12-26.

Sponsored by Alvogen Korea · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
219
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hypertension
  • Cholesterolemia

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Keywords

  • DP-R208
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 219 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Alvogen Korea is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
219 participants (actual)

Study arms

  • Experimental
    CR group

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

    Drug: DP-R208 · Drug: Candesartan32mg Placebo · Drug: Rosuvastatin 20mg Placebo

  • Active comparator
    CP group

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

    Drug: Candesartan32mg · Drug: DP-R208 Placebo · Drug: Rosuvastatin 20mg Placebo

  • Active comparator
    PR group

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

    Drug: Rosuvastatin 20mg · Drug: DP-R208 Placebo · Drug: Candesartan32mg Placebo

Interventions

  • DrugDP-R208

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

  • DrugCandesartan32mg

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

    Also known as: Candesartan

  • DrugRosuvastatin 20mg

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

    Also known as: Rosuvastatin

  • 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

06

What researchers measure

Primary outcomes

  1. Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol

    Time frame: 8weeks

07

Study locations

1 site
  • Korea University Guro Hospital
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Cho KI, Kim BH, Park YH, Ahn JC, Kim SH, Chung WJ, Kim W, Sohn IS, Shin JH, Kim YJ, Chang K, Yu CW, Ahn SH, Kim SY, Ryu JK, Lee JY, Hong BK, Hong TJ, Gyu Park C. Efficacy and Safety of a Fixed-Dose Combination of Candesartan and Rosuvastatin on Blood Pressure and Cholesterol in Patients With Hypertension and Hypercholesterolemia: A Multicenter, Randomized, Double-Blind, Parallel Phase III Clinical Study. Clin Ther. 2019 Aug;41(8):1508-1521. doi: 10.1016/j.clinthera.2019.05.007. Epub 2019 Jul 12. PubMed 31307833 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02770261
Lead sponsor
Alvogen Korea
Responsible party
Sponsor
First posted
May 12, 2016
Start date
Dec 2015
Primary completion
Aug 2016
Completion
Oct 2016
Last update
Dec 26, 2016

Study contacts

Changkyu Park
principal investigator · Korea University Guro Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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