| Trial ID: | L3223 |
| Source ID: | NCT01375322
|
| Associated Drug: |
Amlodipine+Benazepril
|
| Title: |
ADDM Study - Amtrel and Co-Diovan in Type 2 Diabetes Mellitus Hypertension Patients With Microalbuminuria
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hypertension|Diabetes Mellitus, Type 2|Albuminuria
|
| Interventions: |
DRUG: Amlodipine+Benazepril|DRUG: Valsartan+Hydrochlorothiazide
|
| Outcome Measures: |
Primary: To compare the change from baseline in blood pressures (DBP/SBP) to 16-week regimen between Amtrel® and Co-Diovan®, 16-week | Secondary: To compare the response rate (defined as SBP < 130 mmHg and DBP < 80 mmHg) at the end of study, 16-week
|
| Sponsor/Collaborators: |
Sponsor: TSH Biopharm Corporation Limited
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
226
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-06
|
| Completion Date: |
2010-06
|
| Results First Posted: |
|
| Last Update Posted: |
2011-06-17
|
| Locations: |
Chang Gung Memorial Hospital-Kaohsiung, Kaohsiung, 833, Taiwan|Taichung Veterans General Hospital, Taichung, 407, Taiwan|Tri-Service General Hospital, Taipei, 114, Taiwan|Far Eastern Memorial Hospital, Taipei, 220, Taiwan
|
| URL: |
https://clinicaltrials.gov/show/NCT01375322
|
