NCT03860220

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Hyo-Soo Kim · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Dyslipidemias

Interventions

Type	Name	Description
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
DRUG	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

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-01-01
• Completion: 2020-06-01
• First posted: 2019-03-01
• Last updated: 2019-03-01