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Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Rosuvastatin

Primary Purpose

Dyslipidemia With Hypertension

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)
Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo)
Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)
Sponsored by
Jeil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia With Hypertension

Eligibility Criteria

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

Inclusion Criteria:

  • Dyslipidemia with hypertesion
  • msSBP < 180 mmHg
  • msDBP < 110 mmHg
  • LDL-C ≤ 250 mg/dL
  • Triglycerides < 400 mg/dL

Exclusion Criteria:

  • At Visit 3, BP difference SBP ≥20mmHg or DBP ≥10mmHg
  • CK normal range ≥ 2 times
  • Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
  • AST or ALT ≥ 2 times
  • Uncontrolled diabetes mellitus (HbA1c≥9%)
  • CLcr < 30 mL/min/1.73m^2
  • K > 5.5 mEq/L
  • Other exclusion applied

Sites / Locations

  • Chungnam National University Hospital
  • Chonnam National University Hospital
  • Seoul National University Bundang Hospital
  • Gachon University Gil Medical Center
  • Inje University Haeundae Paik Hospital
  • Ewha Womans University Mokdong Hospital
  • Kangbuk Samsung Hospital
  • Korea University Anam Hospital
  • KyungHee University Hospital at Gangdong
  • Seoul National University Hospital
  • SoonChunHyang University Hospital, Seoul
  • The Catholic University of Korea Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Group III

Arm Description

Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin 20 mg for 8 weeks

Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo for 8 weeks

Treatment of Telmisartan 80 mg, Amodipine placebo, Rosuvastatin 20 mg for 8 weeks

Outcomes

Primary Outcome Measures

change of LDL-C
change of msSBP

Secondary Outcome Measures

Full Information

First Posted
March 8, 2017
Last Updated
July 5, 2018
Sponsor
Jeil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03088254
Brief Title
Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Rosuvastatin
Official Title
A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 20, 2016 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
December 4, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with dyslipidemia with hypertension.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin 20 mg for 8 weeks
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo for 8 weeks
Arm Title
Group III
Arm Type
Active Comparator
Arm Description
Treatment of Telmisartan 80 mg, Amodipine placebo, Rosuvastatin 20 mg for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)
Intervention Description
Twinstar(80/10 mg) and Rosuvastatin 20 mg for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo)
Intervention Description
Twinstar(80/10 mg) and Rosuvastatin placebo for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)
Intervention Description
Twinstar placebo, Amlodipine 10 mg and Rosuvastatin 20 mg for 8 weeks
Primary Outcome Measure Information:
Title
change of LDL-C
Time Frame
baseline and 8 weeks
Title
change of msSBP
Time Frame
baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dyslipidemia with hypertesion msSBP < 180 mmHg msDBP < 110 mmHg LDL-C ≤ 250 mg/dL Triglycerides < 400 mg/dL Exclusion Criteria: At Visit 3, BP difference SBP ≥20mmHg or DBP ≥10mmHg CK normal range ≥ 2 times Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times) AST or ALT ≥ 2 times Uncontrolled diabetes mellitus (HbA1c≥9%) CLcr < 30 mL/min/1.73m^2 K > 5.5 mEq/L Other exclusion applied
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KyungHee University Hospital at Gangdong
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
SoonChunHyang University Hospital, Seoul
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30665829
Citation
Hong SJ, Jeong HS, Cho JM, Chang K, Pyun WB, Ahn Y, Hyon MS, Kang WC, Lee JH, Kim HS. Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial. Clin Ther. 2019 Feb;41(2):233-248.e9. doi: 10.1016/j.clinthera.2018.12.008. Epub 2019 Jan 18.
Results Reference
derived

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Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Rosuvastatin

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