Ignite Creation Date:
2024-05-05 @ 11:38 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01375322
Status:
COMPLETED
Last Update Posted:
2011-06-17
First Post:
2011-06-15
Brief Title:
ADDM Study - Amtrel and Co-Diovan in Type 2 Diabetes Mellitus Hypertension Patients With Microalbuminuria
Sponsor:
TSH Biopharm Corporation Limited
Organization:
TSH Biopharm Corporation Limited
Study Overview
Official Title:
Efficacy and Safety of Two Fixed-combination Antihypertensive Regimens Amtrel and Co-Diovan in Type 2 Diabetes Hypertension Patients With Microalbuminuria
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to compare the change from baseline in blood pressures DBPSBP 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 AESAE and laboratory examinations
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 AESAE and laboratory examinations
Detailed Description:
At the screening visit patients who fulfilled the entrance criteria and had given written informed consent entered a placebo running period where they discontinued antihypertensive medication for two weeks During that period Adalat 5mg could be given for emergency At the end of placebo running period those patients became hypertensive ie SBP between 130-180mmHg or DBP between 80-110mmHg were randomized into either treatment group For those patients remaining normotensive continued to be on placebo run-in for another two weeks 10 - 14 days After the two-week 10 - 14 days placebo run-in period those patients became hypertensive were randomized into either treatment group However for those patients remaining normotensive were excluded from the study After randomization into either arm patients entered four months treatment period The dosage adjustment were proceed in order to reach the best effect During the treatment period there was a monthly visit to assess the response of the patients
The starting dose of Amtrel was 1 capsule contains 12 tablet amlodipine benazepril hydrochloride 25 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 SBP130 mmHg and DBP 80 mmHg during treatment period
The starting dose of Co-Diovan was 1 capsule contains 12 tablet valsartan hydrochlorothiazide 40 mg 625 mg every morning and could be adjusted up to 2 capsules contains 1 tablet per capsule valsartan hydrochlorothiazide 160 mg 250 mg every morning if patients did not achieve the criteria of SBP130 mmHg and DBP 80 mmHg during treatment period
All randomized patients attended monthly clinic visits for the 16-week treatment period At week 4 Visit 3 all patients were force-titrated to 1 capsule 1 tablet per capsule for 4 weeks Subsequently those patients did not achieve the target blood pressure SBP130 mmHg and DBP80 mmHg were titrated monthly to next dose level 2 capsule per day
The starting dose of Amtrel was 1 capsule contains 12 tablet amlodipine benazepril hydrochloride 25 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 SBP130 mmHg and DBP 80 mmHg during treatment period
The starting dose of Co-Diovan was 1 capsule contains 12 tablet valsartan hydrochlorothiazide 40 mg 625 mg every morning and could be adjusted up to 2 capsules contains 1 tablet per capsule valsartan hydrochlorothiazide 160 mg 250 mg every morning if patients did not achieve the criteria of SBP130 mmHg and DBP 80 mmHg during treatment period
All randomized patients attended monthly clinic visits for the 16-week treatment period At week 4 Visit 3 all patients were force-titrated to 1 capsule 1 tablet per capsule for 4 weeks Subsequently those patients did not achieve the target blood pressure SBP130 mmHg and DBP80 mmHg were titrated monthly to next dose level 2 capsule per day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None