UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003451 |
|---|---|
| Receipt number | R000004153 |
| Scientific Title | Renoprotective effects of azelnidipine in hypertensive diabetic patients in Mie |
| Date of disclosure of the study information | 2010/04/06 |
| Last modified on | 2012/04/05 14:34:49 |
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Basic information
Public title
Renoprotective effects of azelnidipine in hypertensive diabetic patients in Mie
Acronym
RANDAM
Scientific Title
Renoprotective effects of azelnidipine in hypertensive diabetic patients in Mie
Scientific Title:Acronym
RANDAM
Region
| Japan |
Condition
Condition
essential hypertension with type 2 diabetes mellitus and albuminuria
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Albuminuria is a powerful prognostic predictor of cardiovascular disease in patients with hypertension and diabetes. Several guidelines for the management of hypertension recommend aggressive blood pressure reduction as well as the use of inhibitors of the renin-angiotensin system to slow the decline of kidney function in patients with albuminuria. Most of such patients require a combination of a renin-angiotensin system blocker with either a calcium channel blocker or diuretic to achieve blood pressure goal. Although the GUARD study demonstrated that treatment using an angiotensin converting enzyme inhibitor with a diuretic resulted in a greater reduction in albuminuria compared to the group of angiotensin converting enzyme inhibitor and a calcium channel blocker, amlodipine, some calcium channel blockers, such as azelnidipine, have been reported to exert renoprotective effects. Thus, the present study was designed to test the hypothesis that combining an angiotensin receptor blocker with either a calcium channel blocker, azelnidipine, or a thiazide diuretic will cause similar reductions in blood pressure and albuminuria in patients with hypertension and diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary endpoint is the change in the ratio of urine albumin to creatinine (Alb/Cr) from baseline to week 24.
Key secondary outcomes
(1) The change in the urine Alb/Cr ratio from baseline to week 12.
(2) The change in estimated glomerular filtration ratio from baseline to week 12 and 24.
(3) Proportion of patients who progress to overt diabetic nephropathy
(4) The magnitude of albuminuria
(5) The changes in serum creatinine, potassium, sodium, LDL-cholesterol, HDL-cholesterol, and HbA1c levels
(6) The changes in urine excretion of sodium
(7) The changes in clinic blood pressure and heart rate
(8) The changes in self-measured blood pressure at home
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
RANDAM is a 24-week, prospective, randomized, open, blinded-endpoint (PROBE) study. After a screening phase for eligibility, inhibitors of the renin-angiotensin system, calcium channel blockers, and diuretics are withdrawn. This was followed by a 12-week run-in period where patients are treated with a combination of olmesartan 20mg/day and amlodipine 5mg/day. At the end of the run-in period, baseline data are obtained. Then, amlodipine is withdrawn and patients are assigned to receive azelnidipine 16mg/day in combination with olmesartan 20mg/day for another 24-week (randomization). Antihypertensive drugs other than inhibitors of the renin-angiotensin system, calcium channel blockers, and diuretics are allowed throughout the study period and upward-titration of such medication (alpha-blockers or beta-blockers) is implemented to reach a target clinic blood pressure of <130/80mmHg. Data are obtained at 12- and 24-week. The target of glycemic levels is HbA1c of less than 6.5%. The addition of a thiazolidinedione is not allowed during the study period.
Interventions/Control_2
After a screening phase for eligibility, inhibitors of the renin-angiotensin system, calcium channel blockers, and diuretics are withdrawn. This was followed by a 12-week run-in period where patients are treated with a combination of olmesartan 20mg/day and amlodipine 5mg/day. At the end of the run-in period, baseline data are obtained. Then, amlodipine is withdrawn and patients are assigned to receive trichlorthiazide 1mg/day in combination with olmesartan 20mg/day for another 24-week (randomization). Antihypertensive drugs other than inhibitors of the renin-angiotensin system, calcium channel blockers, and diuretics are allowed throughout the study period and upward-titration of such medication (alpha-blockers or beta-blockers) is implemented to reach a target clinic blood pressure of <130/80mmHg. Data are obtained at 12- and 24-week. The target of glycemic levels is HbA1c of less than 6.5%. The addition of a thiazolidinedione is not allowed during the study period.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients with type 2 diabetes mellitus and albuminuria (30-600mg/g creatinine) with clinic blood pressure >130/80mmHg under a monotherapy with a standard dosage of an inhibitor of the renin-angiotensin system.
Key exclusion criteria
Exclusion criteria are: secondary hypertension; history of acute coronary syndrome, heart failure, coronary revascularization, or stroke within the previous 6 months; uncontrolled diabetes mellitus (HbA1c >9.0%); a disorder that requires treatment with calcium channel blockers or diuretics; confirmed or suspected renal artery stenosis; serum creatinine of 2.0mg/dl or more for men and 1.5mg/dl or more for women; pregnant women; or clinic systolic blood pressure >180mmHg and/or diastolic blood pressure >110mmHg.
Target sample size
146
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Kojima |
Organization
Komono Kosei Hospital
Division name
Department of Internal Mediine
Zip code
Address
75 Fukumura, Komono-cho, Mie
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Komono Kosei Hospital
Division name
Department of Internal Medicine
Zip code
Address
m-kojima@kkh.miekosei.or.jp
TEL
Homepage URL
m-kojima@kkh.miekosei.or.jp
Sponsor or person
Institute
Komono Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
菰野厚生病院（三重県）
いなべ総合病院（三重県）
カトウ医院（三重県）
三重県立総合医療センター（三重県）
坂井橋クリニック（三重県）
主体会病院（三重県）
市立四日市病院（三重県）
武内病院（三重県）
村瀬病院（三重県）
山本総合病院（三重県）
あのつクリニック（三重県）
池田内科循環器科（三重県）
坂倉内科（三重県）
永井病院（三重県）
みやがわクリニック（三重県）
山の手クリニック（三重県）
らんクリニック（三重県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 05 | Day |
Last modified on
| 2012 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004153
