UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of effects of aggressive antihypertensive therapy on renal and vascular endothelial function
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Naoki Kashihara
Organization	Kawasaki Medical School
Division name	Nephrology
Address	577 Matsushima, Kurashiki-Shi, Okayama
TEL	086-462-1111
Email	kashinao@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Norio Komai
Organization	Study group for vascular protection secretariat
Division name	Study group for vascular protection secretariat
Address	Nephrology , Kawasaki Medical School 577 Matsushima , Kurashiki-Shi, Okayama
TEL	086-462-1111
Homepage URL
Email	komai@med.kawasaki-m.ac.jp

Sponsor
Institute	Study group for vascular protection
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000001928