ADDM Study - Amtrel and Co-Diovan in Type 2 Diabetes Mellitus Hypertension Patients With Microalbuminuria
Efficacy and Safety of Two Fixed-combination Antihypertensive Regimens, Amtrel® and Co-Diovan® in Type 2 Diabetes Hypertension Patients With Microalbuminuria
1 other identifier
interventional
226
1 country
4
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
Started Jun 2007
Typical duration for phase_4 hypertension
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 15, 2011
CompletedFirst Posted
Study publicly available on registry
June 17, 2011
CompletedJune 17, 2011
June 1, 2011
3 years
June 15, 2011
June 16, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To compare the change from baseline in blood pressures (DBP/SBP) to 16-week regimen between Amtrel® and Co-Diovan®
16-week
Secondary Outcomes (1)
To compare the response rate (defined as SBP < 130 mmHg and DBP < 80 mmHg) at the end of study
16-week
Study Arms (2)
Co-Diovan® Group
ACTIVE COMPARATORThe starting dose of Co-Diovan® was 1 capsule (contains 1/2 tablet) (valsartan/ hydrochlorothiazide 40 mg/ 6.25 mg) every morning and could be adjusted up to 2 capsules (contains 1 tablet per capsule) (valsartan/ hydrochlorothiazide 160 mg/ 25.0 mg) every morning if patients did not achieve the criteria of SBP\<130 mmHg and DBP\< 80 mmHg during treatment period
Amtrel® Group
EXPERIMENTALThe starting dose of Amtrel® was 1 capsule (contains 1/2 tablet) (amlodipine / benazepril hydrochloride 2.5 mg/ 5 mg) every morning and could be adjusted up to 2 capsules (contains 1 tablet per capsule) (amlodipine / benazepril hydrochloride 10 mg/ 20 mg) every morning if patients did not achieve the criteria of SBP\<130 mmHg and DBP\< 80 mmHg during treatment period
Interventions
Amlodipine besylate 5 mg + Benazepril hydrochloride 10 mg, daily use and forced titrate till 16-week end
Valsartan 80 mg + Hydrochlorothiazide 12.5 mg, daily use and forced titrate till 16-week end
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Chang Gung Memorial Hospital-Kaohsiung
Kaohsiung City, 833, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Far Eastern Memorial Hospital
Taipei, 220, Taiwan
Related Publications (1)
Lee IT, Hung YJ, Chen JF, Wang CY, Lee WJ, Sheu WH. Comparison of the efficacy and safety profiles of two fixed-dose combinations of antihypertensive agents, amlodipine/benazepril versus valsartan/hydrochlorothiazide, in patients with type 2 diabetes mellitus and hypertension: a 16-week, multicenter, randomized, double-blind, noninferiority study. Clin Ther. 2012 Aug;34(8):1735-50. doi: 10.1016/j.clinthera.2012.06.014. Epub 2012 Jul 10.
PMID: 22784975DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wayne H-H Sheu
Taichung Veterans General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 15, 2011
First Posted
June 17, 2011
Study Start
June 1, 2007
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
June 17, 2011
Record last verified: 2011-06