ADDM Study - Amtrel and Co-Diovan in Type 2 Diabetes Mellitus Hypertension Patients With Microalbuminuria
Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
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