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

Hyo-Soo Kim

Status and phase: Unknown; Phase 4

Conditions: Hypertension; Dyslipidemias

Treatments: Drug: NEWSTATIN TS; Drug: CADUET

Study type: Interventional

Funder types: Other

Identifiers

NCT03860220

STAROS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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304 participants in 2 patient groups, including a placebo group

NEWSTATIN TS

Active Comparator group

Description:

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

Treatment:

Drug: NEWSTATIN TS

CADUET

Placebo Comparator group

Description:

Dual therapy (Amlodipine + Atorvastatin 5/10mg)

Treatment:

Drug: CADUET