ADDM Study - Amtrel and Co-Diovan in Type 2 Diabetes Mellitus Hypertension Patients With Microalbuminuria

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2007
The purpose of the study is to compare the change from baseline in blood pressures (DBP/SBP) to 16‐week regimen between Amtrel® and Co‐Diovan®. The secondary objectives were listed as the following. ‐ To compare the response rate (defined as SBP < 130 mmHg and DBP < 80 mmHg) at the end of study ‐ To evaluate the change from baseline in albumin‐to‐creatinine ratio with antihypertensive medications in whole group (combined treatment groups) and each treatment group (Amtrel®, Co‐Diovan®) at Week 16 ‐ The change from baseline in glycosylated hemoglobin (HbA1c) at Week 16 ‐ The change from baseline in fasting plasma glucose (FPG) at Week 16 ‐ The change from baseline in fasting lipid profiles (triglyceride, total cholesterol, high‐density lipoprotein cholesterol, low‐density lipoprotein cholesterol) at Week 16 ‐ The change from baseline in arteriosclerosis marker (brachial‐ankle pulse‐wave velocity (ba‐PWV) and ankle‐brachial pressure index (ABI), using Colin‐VP1000) at Week 16 ‐ The change from baseline on the body mass index (BMI) and waist‐hip ratio (WHR) at each specified study time point ‐ To ascertain the safety and tolerability of Amtrel® versus Co‐Diovan® including AE/SAE, and laboratory examinations
Epistemonikos ID: 7536f6adfb488d2a9e2d75a629386c807c2b4eff
First added on: May 06, 2024