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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

Primary Purpose

Hypertension, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Telmisartan + Amlodipine + Rosuvastatin
Telmisartan + Amlodipine
Telmisartan + Rosuvastatin
Sponsored by
Daewon Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sevrance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Test

Reference 1

Reference 2

Arm Description

qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin)

qd PO, Micardis(telmisartan) + Crestor(rosuvastatin)

qd PO,Twynsta(telmisartan/amlodipine)

Outcomes

Primary Outcome Measures

Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline
Change of LDL-C(Low Density Lipid Cholesterol) from baseline

Secondary Outcome Measures

Full Information

First Posted
October 12, 2016
Last Updated
January 30, 2018
Sponsor
Daewon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03210532
Brief Title
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 Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 7, 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
qd PO, Twynsta(telmisartan/amlodipine) + Crestor(rosuvastatin)
Arm Title
Reference 1
Arm Type
Active Comparator
Arm Description
qd PO, Micardis(telmisartan) + Crestor(rosuvastatin)
Arm Title
Reference 2
Arm Type
Active Comparator
Arm Description
qd PO,Twynsta(telmisartan/amlodipine)
Intervention Type
Drug
Intervention Name(s)
Telmisartan + Amlodipine + Rosuvastatin
Intervention Description
Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo
Intervention Type
Drug
Intervention Name(s)
Telmisartan + Amlodipine
Intervention Description
Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo
Intervention Type
Drug
Intervention Name(s)
Telmisartan + Rosuvastatin
Intervention Description
Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo
Primary Outcome Measure Information:
Title
Change of MSSBP(Mean Sit Systolic Blood Pressure) from baseline
Time Frame
8-week
Title
Change of LDL-C(Low Density Lipid Cholesterol) from baseline
Time Frame
8-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sevrance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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