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Handok Enters Phase II Study for Hypertension Combination Therapy

  • Date
    2020.09.09 13:58
  • Views
    4,527

Handok’s (Chairman & CEO Young-jin Kim, Vice President Jin-ki Paik) hypertension combination therapy has entered Phase II clinical trials.

Handok, in collaboration with Sanofi, is developing a combination therapy for hypertension composed of Irbesartan, an angiotensin II receptor blocker (ARB), and Amlodipine, a calcium channel blocker (CCB). Currently, there are various types of ARB-CCB combination therapies, but none combining Irbesartan with Amlodipine.

In May this year, Handok won approval for its clinical trial Phase II plan (Investigational New Drug (IND) Application) from the Ministry of Food and Drug Safety and administered the drug to its first patient in May. It has also acquired IRB (Institutional Review Board) approval from around 30 institutions, including major hospitals, such as Yonsei University Severance Hospital, Seoul National University Hospital, Korea University Anam Hospital, the Catholic University of Korea Seoul St. Mary’s Hospital.

The purpose of the clinical trial is to compare and evaluate the validity and safety of the combination and single treatments of irbesartan and amlodipine for patients with essential hypertension. The clinical trial will target adults from ages 19 to 75 years and is set for completion in February 2021.

Hypertension combination therapy reduces the number of medications patients must take into one single medication, offering both increased convenience and compliance. Furthermore, it can offer assistance to hypertension patients who have not experienced satisfactory results with a single therapy or existing hypertension therapies.

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