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

A

Alvogen

Status and phase

Completed
Phase 3

Conditions

Cholesterolemia
Hypertension

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT02770261
DP-CTR208-III-03

Details and patient eligibility

About

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

Enrollment

219 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

219 participants in 3 patient groups

CR group
Experimental group
Description:
DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla
Treatment:
Drug: DP-R208
Drug: Rosuvastatin 20mg Placebo
Drug: Candesartan32mg Placebo
CP group
Active Comparator group
Description:
DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla
Treatment:
Drug: Candesartan32mg
Drug: Rosuvastatin 20mg Placebo
Drug: DP-R208 Placebo
PR group
Active Comparator group
Description:
DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg
Treatment:
Drug: Rosuvastatin 20mg
Drug: DP-R208 Placebo
Drug: Candesartan32mg Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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