NCT04061824

Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia

Open-label, Randomized, Single Center, Paralleled Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Hypertension and dyslipidemia are very prevalent diseases in general population, and the prevalence is keep increasing especially on population with advanced age. Both diseases are major risk factor of cardiovascular disease, and many complication could be induced if not managed properly. Also, these diseases need consistent medication for long time, so the compliance to the treatment is an important issue for these diseases. Treatment effect of olmesartan to hypertension and rosuvastatin to dyslipidemia is already proven in previous studies, and these medication does not have interaction with each other. By using fixed-dose combination of these drugs, the investigators could improve the compliance to medication, and may have better treatment effect. In this single center, randomized, phase 4 clinical trial, the investigators divided patients into 2 groups, one with fixed-dose combination of 2 drugs, while another with 2 separated drugs. Each patient in this study was evaluated at first visit, and outcomes are evaluated at 26 weeks after the start point of medication. The primary outcome of this study was compliance of prescribe medication, and the secondary outcome was blood pressure (systolic, diastolic), cholesterol, and low density lipoprotein cholesterol.

Conditions

• Hypertension
• Dyslipidemias

Interventions

Type	Name	Description
DRUG	Olostar Tab (olmesartan/rosuvastatin FDC(fixed dose combination))	In intervention group, patients had a pill of fixed-dose combination of Olmesartan medoxomil and Rosuvastatin, rather taking separated two pills.
DRUG	Two separated drugs(ARB(Angiotensin Ⅱ receptor blocker) and statin)	In control group, patients had two separated pills for hypertension and dyslipidemia. One of ARBs(Valsartan, Olmesartan, Candesartan, Telmisartan, Fimasartan, Losartan and Irbesartan) and one of statins(Rosuvastatin, Atorvastatin, Pitavastatin, Simvastatin, Pravastatin, Fluvastatin and Atorvastatin/Ezetimibe).

Timeline

• Start date: 2016-05-24
• Primary completion: 2018-12-20
• Completion: 2018-12-20
• First posted: 2019-08-20
• Last updated: 2019-08-21

Locations

1 site across 1 country: South Korea