Jeil Pharmaceutical said Monday that it has published the phase 3 clinical trial results for Telmiduo Plus, an anti-hypertension and dyslipidemia treatment, in an international journal.
Telmiduo Plus is a combination treatment, which three substances -- angiotensin II receptor blocker-based telmisartan, calcium channel blocker-based amlodipine, and statin-based rosuvastatin.
The published study, titled “Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial,” is a multicenter open-label, randomized, controlled phase 3 clinical study conducted at eight university hospitals in Korea. Professor Kim Hyo-soo of the Cardiovascular Center of Seoul National University Hospital served as the head researcher.
The company randomly divided 148 patients with dyslipidemia and hypertension into three groups -- telmisartan, amlodipine and rosuvastatin, telmisartan and amlodipine (control group 1), and telmisartan and rosuvastatin (control group 2) – for eight weeks.
The results showed that the mean sitting systolic blood pressure for patient subscribed with telmisartan, amlodipine and rosuvastatin decreased 24 mmHg at week eight compared with 15 mmHg decrease from the control group 2, demonstrating the superiority of controlling hypertension.
Also, low-density lipoprotein-cholesterol levels of telmisartan, amlodipine, and rosuvastatin treated group was 58 percent lower than baseline at week eight which was 64 percent lower than control group 1.
The expression of adverse events was similar to that of the control group and found that there was no overlapping additive toxicity when referencing the reported safety information for each preparation.
“Telmiduo Plus has the effect of reducing the number of pills taken by patients suffering from the disease, which in turn, can have good effects such as cost reduction, improvement of compliance with the medication, and an increase of the cure rate,” Professor Kim said.
The results of the clinical trial were published in the Clinical Therapeutics.
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