drugset / Trial / NCT04061824

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

NCT04061824

Phase 4 Completed 150 enrolled Yonsei University
RandomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2016-05-24
Primary completion
2018-12-20
Completion
2018-12-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Olmesartan medoxomil Unknown
Subject Rosuvastatin Small molecule
Comparator Atorvastatin Small molecule
Comparator Candesartan Unknown
Comparator Fimasartan Small molecule
Comparator Fluvastatin Other / unclassified
Comparator Irbesartan Small molecule
Comparator Losartan Other / unclassified
Comparator Olmesartan Other / unclassified
Comparator Pitavastatin Small molecule
Comparator Pravastatin Small molecule
Comparator Simvastatin Small molecule
Comparator Telmisartan Other / unclassified
Comparator Valsartan Small molecule