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

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ClinicalTrials.gov Identifier: NCT02770261
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : December 26, 2016
Sponsor:
Information provided by (Responsible Party):
Alvogen Korea

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.

Condition or disease Intervention/treatment Phase
Hypertension Cholesterolemia Drug: DP-R208 Drug: Candesartan32mg Drug: Rosuvastatin 20mg Drug: DP-R208 Placebo Drug: Candesartan32mg Placebo Drug: Rosuvastatin 20mg Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : December 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: CR group
DP-R208+Candesartan 32mg pla+Rosuvastatin 20mg pla
Drug: DP-R208
DP-R208 + Candesartan 32mg placebo + Rosuvastatin 20mg placebo

Drug: Candesartan32mg Placebo
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

Drug: Rosuvastatin 20mg Placebo
DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo

Active Comparator: CP group
DP-R208 pla+Candesartan 32mg+Rosuvastatin 20mg pla
Drug: Candesartan32mg
DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo
Other Name: Candesartan

Drug: DP-R208 Placebo
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

Drug: Rosuvastatin 20mg Placebo
DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo

Active Comparator: PR group
DP-R208 pla+Candesartan 32mg pla+Rosuvastatin 20mg
Drug: Rosuvastatin 20mg
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
Other Name: Rosuvastatin

Drug: DP-R208 Placebo
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg

Drug: Candesartan32mg Placebo
DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg




Primary Outcome Measures :
  1. Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol [ Time Frame: 8weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770261


Locations
Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Alvogen Korea
Investigators
Principal Investigator: Changkyu Park Korea University Guro Hospital

Responsible Party: Alvogen Korea
ClinicalTrials.gov Identifier: NCT02770261     History of Changes
Other Study ID Numbers: DP-CTR208-III-03
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alvogen Korea:
DP-R208

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Candesartan
Candesartan cilexetil
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists