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The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin

Primary Purpose

Hypertension, Dyslipidemias

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

NEWSTATIN TS

CADUET

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

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

Inclusion Criteria:

145 mmHg ≤ msSBP ≤ 190 mmHg
Triglycerides < 500 mg/dL
LDL-C ≤ 250 mg/dL

Exclusion Criteria:

sSBP ≥ 20mmHg and sDBP ≥ 10mmHg
symptomatic orthostatic hypotension and secondary/iatrogenic hypertension and dyslipidemia
history of moderate to severe cerebral ischemia, cerebral hemorrhage, transient ischemic attack, myocardial infarction, or unstable angina in the past 6 months; severe heart failure (New York Heart Association functional class III and IV)
hypersensitivity to telmisartan or rosuvastatin
history of angioedema after treatment with angiotensin-converting enzyme inhibitors or ARBs; creatinine phosphokinase levels ≥3 times the upper limit of normal
estimated glomerular filtration rate ≤30 mL/min; aspartate aminotransferase and alanine aminotransferase levels ≥3 times the upper limit of normal
potassium levels >5.5 mmol/L; or any diseases that could affect the results of the study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NEWSTATIN TS

CADUET

Arm Description

Triple therapy (Telmisartan + Amlodipine + Rosuvastatin 40/5/10mg)

Dual therapy (Amlodipine + Atorvastatin 5/10mg)

Outcomes

Primary Outcome Measures

Percent changes in mean sitting systolic blood pressure (MSSBP)

Percent changes in MSSBP from baseline after 8 weeks of treatment

Percent changes in LDL-C

Percent changes in LDL-C from baseline after 8 weeks of treatment

Secondary Outcome Measures

Percent changes in LDL-C

Percent changes in LDL-C from baseline after 4 weeks of treatment

Percent changes in TC

Percent changes in TC from baseline after 4 and 8 weeks of treatment

Percent changes in TG

Percent changes in TG from baseline after 4 and 8 weeks of treatment

Percent changes in HDL-C

Percent changes in HDL-C from baseline after 4 and 8 weeks of treatment

Percent changes in Non-HDL-C

Percent changes in Non-HDL-C from baseline after 4 and 8 weeks of treatement

Percent changes in Apo B

Percent changes in Apo B from baseline after 4 and 8 weeks of treatment

Percent changes in Apo A-I

Percent changes in Apo A-I from baseline after 4 and 8 weeks of treatment

Percent changes in LDL-C/HDL-C ratio

Percent changes in LDL-C/HDL-C from baseline after 4 and 8 weeks of treatement

Percent changes in Apo B/Apo A-I ratio

Percent changes in Apo B/Apo A-I from baseline after 4 and 8 weeks of treatment

Percent changes in hs-CRP

Percent changes in hs-CRP from baseline after 4 and 8 weeks of treatment

The percentage of patients achieving treatment goal for blood pressure and LDL-C

Changes in mean sitting systolic/diastolic blood pressure

Changes in mean sitting systolic/diastolic blood pressure after 4 and 8 weeks of treatment

Full Information

NCT ID

NCT03860220

First Posted

January 14, 2019

Last Updated

February 28, 2019

Sponsor

Hyo-Soo Kim

1. Study Identification

Unique Protocol Identification Number

NCT03860220

Brief Title

The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin

Official Title

A Multi-center, Randomized, Parallel Phase IV 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

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2019 (Anticipated)

Primary Completion Date

January 1, 2020 (Anticipated)

Study Completion Date

June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hyo-Soo Kim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The goal of this study was to assess the efficacy and safety of FDC therapy with triple therapy of Telmisartan 40 mg/Amlodipine 5 mg/Rosuvastatin 10mg in Korean patients with both hypertension and dyslipidemia.

Detailed Description

Patients were randomly assigned to 2 groups: (1) Triple therapy (40mg of telmisartan and 5mg of amlodipine and 10mg of rosuvastatin); (2) Dual therapy (5mg of amlodipine and 10mg of atorvastatin). After 8 weeks of treatment, the change in mean sitting systolic blood pressure (MSSBP) and the percent change in LDL-C between 2 group, will be compared.

6. Conditions and Keywords

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

Hypertension, Dyslipidemias

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NEWSTATIN TS

Arm Type

Active Comparator

Arm Description

Triple therapy (Telmisartan + Amlodipine + Rosuvastatin 40/5/10mg)

Arm Title

CADUET

Arm Type

Placebo Comparator

Arm Description

Dual therapy (Amlodipine + Atorvastatin 5/10mg)

Intervention Type

Drug

Intervention Name(s)

NEWSTATIN TS

Other Intervention Name(s)

Newstatin TS 40/5/10mg

Intervention Description

Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with triple therapy (Newstatin TS 40/5/10mg) ; 1 tab qd for 8 weeks

Intervention Type

Drug

Intervention Name(s)

CADUET

Other Intervention Name(s)

Caduet 5/10mg

Intervention Description

Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with dual therapy (Caduet 5/10mg) ; 1 tab qd for 8 weeks

Primary Outcome Measure Information:

Title

Percent changes in mean sitting systolic blood pressure (MSSBP)

Description

Percent changes in MSSBP from baseline after 8 weeks of treatment

Time Frame

8 weeks

Title

Percent changes in LDL-C

Description

Percent changes in LDL-C from baseline after 8 weeks of treatment

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Percent changes in LDL-C

Description

Percent changes in LDL-C from baseline after 4 weeks of treatment

Time Frame

4 weeks

Title

Percent changes in TC

Description

Percent changes in TC from baseline after 4 and 8 weeks of treatment

Time Frame

4, 8weeks

Title

Percent changes in TG

Description

Percent changes in TG from baseline after 4 and 8 weeks of treatment

Time Frame

4, 8weeks

Title

Percent changes in HDL-C

Description

Percent changes in HDL-C from baseline after 4 and 8 weeks of treatment

Time Frame

4, 8weeks

Title

Percent changes in Non-HDL-C

Description

Percent changes in Non-HDL-C from baseline after 4 and 8 weeks of treatement

Time Frame

4, 8weeks

Title

Percent changes in Apo B

Description

Percent changes in Apo B from baseline after 4 and 8 weeks of treatment

Time Frame

4, 8weeks

Title

Percent changes in Apo A-I

Description

Percent changes in Apo A-I from baseline after 4 and 8 weeks of treatment

Time Frame

4, 8weeks

Title

Percent changes in LDL-C/HDL-C ratio

Description

Percent changes in LDL-C/HDL-C from baseline after 4 and 8 weeks of treatement

Time Frame

4, 8weeks

Title

Percent changes in Apo B/Apo A-I ratio

Description

Percent changes in Apo B/Apo A-I from baseline after 4 and 8 weeks of treatment

Time Frame

4, 8weeks

Title

Percent changes in hs-CRP

Description

Percent changes in hs-CRP from baseline after 4 and 8 weeks of treatment

Time Frame

4, 8weeks

Title

The percentage of patients achieving treatment goal for blood pressure and LDL-C

Description

The percentage of patients achieving treatment goal for blood pressure and LDL-C

Time Frame

8 weeks

Title

Changes in mean sitting systolic/diastolic blood pressure

Description

Changes in mean sitting systolic/diastolic blood pressure after 4 and 8 weeks of treatment

Time Frame

4, 8weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 145 mmHg ≤ msSBP ≤ 190 mmHg Triglycerides < 500 mg/dL LDL-C ≤ 250 mg/dL Exclusion Criteria: sSBP ≥ 20mmHg and sDBP ≥ 10mmHg symptomatic orthostatic hypotension and secondary/iatrogenic hypertension and dyslipidemia history of moderate to severe cerebral ischemia, cerebral hemorrhage, transient ischemic attack, myocardial infarction, or unstable angina in the past 6 months; severe heart failure (New York Heart Association functional class III and IV) hypersensitivity to telmisartan or rosuvastatin history of angioedema after treatment with angiotensin-converting enzyme inhibitors or ARBs; creatinine phosphokinase levels ≥3 times the upper limit of normal estimated glomerular filtration rate ≤30 mL/min; aspartate aminotransferase and alanine aminotransferase levels ≥3 times the upper limit of normal potassium levels >5.5 mmol/L; or any diseases that could affect the results of the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hak Seung Lee

Phone

82-10-3166-8399

cardiolee@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yuehee Yeom

turtree@naver.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyo-Soo Kim

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin

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