Evaluating a new combination therapy for high blood pressure and diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy and safety of a combination therapy involving BR1019A and BR1019B in patients suffering from essential hypertension and type 2 diabetes mellitus. Participants will be required to discontinue their current antihypertensive and/or oral hypoglycemic medications, except for Metformin, to evaluate the effects of the new treatment. The study is designed as a Phase 3 interventional trial, indicating a focus on confirming the effectiveness and monitoring the safety of the therapy in a larger patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Those with type 2 diabetes mellitus \& essential hypertension
* Those who agree to discontinue existing antihypertensive and/or oral hypoglycemic drugs during the clinical trial
* Those who are judged medically reasonable by investigator to be able to discontinue existing antihypertensive and/or oral hypoglycemic drugs(except for Metformin) during the clinical trial

Exclusion Criteria:

* Those who meet the following criteria

  * Those with a history of secondary hypertension or suspected secondary hypertension; (Including but not limited to; e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)
  * Those with clinical significant orthostatic hypotension accompanied by symptoms
  * Those with diabetes mellitus taking renin inhibitors(Aliskiren) or moderate to severe renal impairment
  * Those with diabetic nephropathy taking ACE inhibitors
  * Those with type 1 diabetes mellitus, secondary diabetes mellitus, severe insulin-dependent diabetes, diabetic ketoacidosis or lactic acidosis
  * Those with uncontrolled, severe diabetic complications (Micro-vascular complications(e.g., nephropathy, retinopathy, neuropathy, etc.), Macro-vascular complications)
  * Diabetic coma or pre-coma

Where it's running

• Rumah Sakit Jantung dan Pembuluh Darah Harapan Kita (RSJPD)
  Jakarta, DKI Jakarta, Indonesia Recruiting
• Severance Hospital
  Seoul, South Korea Recruiting
• Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Shin-young Oh
• Email: syoh@boryung.co.kr
• Phone: +82-2-708-8000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.