UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000001629 |
|---|---|
| Receipt number | R000001928 |
| Scientific Title | Examination of effects of aggressive antihypertensive therapy on renal and vascular endothelial function |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2016/04/02 09:10:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of effects of aggressive antihypertensive therapy on renal and vascular endothelial function
Acronym
ATTACK ( Antihypertensive Therapy for vascular endothelial function and kidney)
Scientific Title
Examination of effects of aggressive antihypertensive therapy on renal and vascular endothelial function
Scientific Title:Acronym
ATTACK ( Antihypertensive Therapy for vascular endothelial function and kidney)
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare effects on renal and vascular endothelial function betoween the losartan/HCTZ group and the losartan 50mg and amlodipine 5mg combination group in patients with essential hypertension uncontrolled by monotherapy with renin-angiotensin system (RAS) blockers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Change in microalbuminuria after 48 weeks of treatment
Key secondary outcomes
-Change and % change in flow-mediated vasodilatation (FMD) and cardio ankle vascular index (CAVI) after 48 weeks of treatment [only in patients with microalbuminuria (8-299 mg/g Cr) during the observation period]
- Change and %change in microalbuminuria (excludin change after 48 weeks of treatment), uric acid in urine, Na in urine, eGFR, hs-CRP, BNP, serum uric acid, Na, K, Cl, P after 12 and 48 weeks of treatment
- Change and % ahange in L-FABP in urine, 8OHdG in urine, homocysteine, plasma ADMA after 12 and 48 weeks of treatment [only in patients with microalbuminuria (8-299 mg/g Cr) during the observation period]
-Change and %change in office/causual blood pressure after 12, 24, 36 and 48 weeks of treatment
-Cost of antihypertensive ddrug used during the study period
-Safety throughout the study period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
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
Losartan / HCTZ group
Interventions/Control_2
Losartan (50 mg) and amlodipine (5 mg) combination group
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male
Key inclusion criteria
1) Patients with essential hypertension, who have been previously treated with monotherapy of an RAS blocker for 4 weeks or more, however, the target blood pressure defined by the guideline for treatment of hypertension has not been achieved
2) Outpatients aged 30 to 75 years at the time of the first visit
3) Patients who fully understand the study procedures and have given written informed consent to participate in the study
Key exclusion criteria
1) Patients with overt nephropathy (microalbuminuria more than 300 mg/g Cr)
2) Patients with uncontrolled hypertension (systolic blood pressure more than 180mmHg or diastolic blood pressure more than 110mmHg at the time of informed consent)
3) Patients with malignant hypertension
4) Patients with secondary hypertension
5) Patients with liver dysfunction (ALT or AST over three times the normal value)
6) Patients with a previous history of gout attack
7) Patients who have critical cardiovascular complications that required hospitalization within 6 months prior to informed consent
8) Pregnant or breast feeding female patients, including one trying to conceive pregnancy during the planned study period
9) Patients with cardiac insufficiency (above NYHA grade III)
10) Patients with uncontrolled arrhythmia
11) Patients under treatment with diuretics
12) Patients with a history of hypersensitivity to ingredients of the study drugs
13) Patients who are considered not eligible for the study by the attending doctor due to medical reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Kashihara |
Organization
Kawasaki Medical School
Division name
Nephrology
Zip code
Address
577 Matsushima, Kurashiki-Shi, Okayama
TEL
086-462-1111
kashinao@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norio Komai |
Organization
Study group for vascular protection secretariat
Division name
Study group for vascular protection secretariat
Zip code
Address
Nephrology , Kawasaki Medical School 577 Matsushima , Kurashiki-Shi, Okayama
TEL
086-462-1111
Homepage URL
komai@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Study group for vascular protection
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation , Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 01 | 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
| 2008 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 10 | Day |
Last modified on
| 2016 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001928
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
