search
Back to results

Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia

Primary Purpose

Hypertension, Hyperlipidemia

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Telmisartan 80mg
Rosuvastatin 20mg
Rosuvastatin 10mg
Placebo(for Telmisartan 80mg)
Placebo(for Rosuvastatin 20mg)
Placebo(for Rosuvastatin 10mg)
Sponsored by
IlDong 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 - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed Informed Consent
  • Men and women >18 years of age
  • Subject who has one of 3 conditions classifed by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, Coronary Artery Disease and Equivalent

Exclusion Criteria:

  • Female who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study,.
  • Other exclusions applied

Sites / Locations

  • The Catholic University of Saint Mary's HosiptalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Telmisartan 80mg & Rosuvastatin 20mg

Telmisartan 80mg & Rosuvastatin 10mg

Telmisartan placebo & Rosuvastatin 20mg

Telmisartan Placebo & Rosuvastatin 10mg

Telmisartan 80mg & Rosuvastatin placebo

Telmisartan placebo & Rosuvastatin placebo

Arm Description

PO, Once Daily, 8 weeks

PO, Once Daily, 8weeks

PO, Once Daily, 8 weeks

PO, Once Daily, 8 weeks

PO, Once Daily, 8 weeks

PO, Once Daily, 8 weeks

Outcomes

Primary Outcome Measures

•Change in seated diastolicblood pressure at 8 weeks compared to the base value
Change in LDL-Cat 8 weeks compared to the base value (% change)

Secondary Outcome Measures

Change in seateddiastolic blood pressure
Change in seated systolic blood pressure
Rate of patients achieving a therapeutic purpose according to JNC VII Guideline [therapeutic purpose for blood pressure: < 140/90 mmHg (however, < 130/80 mmHg for Group III)]
Change in LDL-Cat compared to the base value (% change)
Change in TC, TG, HDL-C and Apolipoprotein B compared to the base value (% change)
Rate of patients achieving a therapeutic purpose according to NCEP ATP III Guideline therapeutic purpose for LDL-C- (Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL)

Full Information

First Posted
March 5, 2014
Last Updated
March 13, 2014
Sponsor
IlDong Pharmaceutical Co Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT02087540
Brief Title
Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia
Official Title
A Randomized, Double-blind, Multi-center, Factorial Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telmisartan 80mg & Rosuvastatin 20mg
Arm Type
Experimental
Arm Description
PO, Once Daily, 8 weeks
Arm Title
Telmisartan 80mg & Rosuvastatin 10mg
Arm Type
Experimental
Arm Description
PO, Once Daily, 8weeks
Arm Title
Telmisartan placebo & Rosuvastatin 20mg
Arm Type
Active Comparator
Arm Description
PO, Once Daily, 8 weeks
Arm Title
Telmisartan Placebo & Rosuvastatin 10mg
Arm Type
Active Comparator
Arm Description
PO, Once Daily, 8 weeks
Arm Title
Telmisartan 80mg & Rosuvastatin placebo
Arm Type
Active Comparator
Arm Description
PO, Once Daily, 8 weeks
Arm Title
Telmisartan placebo & Rosuvastatin placebo
Arm Type
Placebo Comparator
Arm Description
PO, Once Daily, 8 weeks
Intervention Type
Drug
Intervention Name(s)
Telmisartan 80mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 20mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 10mg
Intervention Type
Drug
Intervention Name(s)
Placebo(for Telmisartan 80mg)
Intervention Type
Drug
Intervention Name(s)
Placebo(for Rosuvastatin 20mg)
Intervention Type
Drug
Intervention Name(s)
Placebo(for Rosuvastatin 10mg)
Primary Outcome Measure Information:
Title
•Change in seated diastolicblood pressure at 8 weeks compared to the base value
Time Frame
at the 8 weeks
Title
Change in LDL-Cat 8 weeks compared to the base value (% change)
Time Frame
at the 8 weeks
Secondary Outcome Measure Information:
Title
Change in seateddiastolic blood pressure
Time Frame
at 2,4 8 weeks
Title
Change in seated systolic blood pressure
Time Frame
at 2,4,8weeks
Title
Rate of patients achieving a therapeutic purpose according to JNC VII Guideline [therapeutic purpose for blood pressure: < 140/90 mmHg (however, < 130/80 mmHg for Group III)]
Time Frame
at 2, 4 and 8 weeks
Title
Change in LDL-Cat compared to the base value (% change)
Time Frame
2, 4 and 8 weeks
Title
Change in TC, TG, HDL-C and Apolipoprotein B compared to the base value (% change)
Time Frame
at 2, 4 and 8 weeks
Title
Rate of patients achieving a therapeutic purpose according to NCEP ATP III Guideline therapeutic purpose for LDL-C- (Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL)
Time Frame
at 2, 4 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent Men and women >18 years of age Subject who has one of 3 conditions classifed by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, Coronary Artery Disease and Equivalent Exclusion Criteria: Female who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study,. Other exclusions applied
Facility Information:
Facility Name
The Catholic University of Saint Mary's Hosiptal
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wook-seong chung, MD
Email
chungws@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
wook-seong Chung, MD

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia

We'll reach out to this number within 24 hrs