Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia

January 30, 2018 updated by: Daewon Pharmaceutical Co., Ltd.
A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults both male and female who are ≥19,<80 years old
  • at screening, 140mmHg≤ SBP<180mmHg & 90mmHg≤ DBP<110mmHg & LDL-C≤250mg/dL & triglyceride<400mg/dL

Exclusion Criteria:

  • at screening, the difference BP of one-side arm is SBP ≥ 20mmHg and DBP ≥ 10mmHg
  • secondary hypertension or secondary dyslipidemia
  • patients who have uncontrolled diabetes melitus, hyper/hypothyroidism or cardiac disease
  • women who are pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin)
Drug: Telmisartan + Amlodipine + Rosuvastatin
Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo
Active Comparator: Reference 1
qd PO, Micardis(telmisartan) + Crestor(rosuvastatin)
Drug: Telmisartan + Rosuvastatin
Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo
Active Comparator: Reference 2
qd PO,Twynsta(telmisartan/amlodipine)
Drug: Telmisartan + Amlodipine
Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline
Time Frame: 8-week
8-week
Change of LDL-C(Low Density Lipid Cholesterol) from baseline
Time Frame: 8-week
8-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

July 4, 2017

First Posted (Actual)

July 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW1501-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Telmisartan + Amlodipine + Rosuvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe