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: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TSH Biopharm Corporation Limited
• Treatments: Amlodipine; Benazepril; Hydrochlorothiazide; Valsartan

Criteria

Inclusion Criteria:

• type 2 diabetes with stable controlled (HbA1c between 6.5-10%)

• SBP between 130-180mmHg or DBP between 80-110mmHg

• microalbuminuria (UAE 30-300mg/24hrs or creatinine 30-300mg/g)

Exclusion Criteria:

• IDDM or secondary forms of diabetes

• hepatic and/or renal dysfunction

• serum potassium level > 5.5mmol/L

• severe renal disease

• Chronic Heart Failure (NYHA class III or IV)

• unstable CV disease

• PTCA within 3 months