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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03860220
• Other study ID #: STAROS
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: February 2019
• Source: Seoul National University Hospital
• Contact: Hak Seung Lee
• Phone: 82-10-3166-8399
• Email: cardiolee[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 304
• Est. completion date: June 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• NEWSTATIN TS
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
• CADUET
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hyo-Soo Kim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent changes in mean sitting systolic blood pressure (MSSBP)	Percent changes in MSSBP from baseline after 8 weeks of treatment	8 weeks
Primary	Percent changes in LDL-C	Percent changes in LDL-C from baseline after 8 weeks of treatment	8 weeks
Secondary	Percent changes in LDL-C	Percent changes in LDL-C from baseline after 4 weeks of treatment	4 weeks
Secondary	Percent changes in TC	Percent changes in TC from baseline after 4 and 8 weeks of treatment	4, 8weeks
Secondary	Percent changes in TG	Percent changes in TG from baseline after 4 and 8 weeks of treatment	4, 8weeks
Secondary	Percent changes in HDL-C	Percent changes in HDL-C from baseline after 4 and 8 weeks of treatment	4, 8weeks
Secondary	Percent changes in Non-HDL-C	Percent changes in Non-HDL-C from baseline after 4 and 8 weeks of treatement	4, 8weeks
Secondary	Percent changes in Apo B	Percent changes in Apo B from baseline after 4 and 8 weeks of treatment	4, 8weeks
Secondary	Percent changes in Apo A-I	Percent changes in Apo A-I from baseline after 4 and 8 weeks of treatment	4, 8weeks
Secondary	Percent changes in LDL-C/HDL-C ratio	Percent changes in LDL-C/HDL-C from baseline after 4 and 8 weeks of treatement	4, 8weeks
Secondary	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	4, 8weeks
Secondary	Percent changes in hs-CRP	Percent changes in hs-CRP from baseline after 4 and 8 weeks of treatment	4, 8weeks
Secondary	The percentage of patients achieving treatment goal for blood pressure and LDL-C	The percentage of patients achieving treatment goal for blood pressure and LDL-C	8 weeks
Secondary	Changes in mean sitting systolic/diastolic blood pressure	Changes in mean sitting systolic/diastolic blood pressure after 4 and 8 weeks of treatment	4, 8weeks