Clinical Trials Logo
  1. Home
  2. Hypertension
  3. NCT02770261
  4. Details
NCT02770261 Clinical Trial

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

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02770261
Other study ID # DP-CTR208-III-03
Secondary ID
Status Completed
Phase Phase 3
First received May 11, 2016
Last updated December 23, 2016
Start date December 2015
Est. completion date October 2016

Study information
Verified date December 2016
Source Alvogen Korea
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 219
Est. completion date October 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Alvogen Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change of mean seated Systolic Blood Pressure and Percent change of LDL cholesterol 8weeks No
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A