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

Dyslipidemia With Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088254
• Other study ID #: J-TAROS-RCT
• Status: Completed
• Phase: Phase 3
• Start date: September 20, 2016
• Est. completion date: December 4, 2017

Study information

• Verified date: March 2018
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 4, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia With Hypertension
• Dyslipidemias
• Hypertension

Intervention

Drug:
• Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)
Twinstar(80/10 mg) and Rosuvastatin 20 mg for 8 weeks
• Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo)
Twinstar(80/10 mg) and Rosuvastatin placebo for 8 weeks
• Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)
Twinstar placebo, Amlodipine 10 mg and Rosuvastatin 20 mg for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inje University Haeundae Paik Hospital	Pusan
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	KyungHee University Hospital at Gangdong	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	SoonChunHyang University Hospital, Seoul	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of LDL-C		baseline and 8 weeks
Primary	change of msSBP		baseline and 8 weeks