UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000816 |
|---|---|
| Receipt number | R000000978 |
| Scientific Title | Aichi - Research on Combination therapy in Hypertension (ARCH): Multi-center observational study on hypertensive's actual condition and effectiveness of the patient preference on an ARB and diuretic combination therapy in hypertensive patients who are under drug treatment |
| Date of disclosure of the study information | 2007/09/03 |
| Last modified on | 2010/03/05 16:18:54 |
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Basic information
Public title
Aichi - Research on Combination therapy in Hypertension (ARCH):
Multi-center observational study on hypertensive's actual condition and effectiveness of the patient preference on an ARB and diuretic combination therapy in hypertensive patients who are under drug treatment
Acronym
Aichi - Research on Combination therapy in Hypertension(Arch)
Scientific Title
Aichi - Research on Combination therapy in Hypertension (ARCH):
Multi-center observational study on hypertensive's actual condition and effectiveness of the patient preference on an ARB and diuretic combination therapy in hypertensive patients who are under drug treatment
Scientific Title:Acronym
Aichi - Research on Combination therapy in Hypertension(Arch)
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In a project to enforce the drug management of hypertension, an observational study is conducted on effectiveness and the patient preference of a combination drug of ARB and diuretic, Preminent. The effectiveness was measured by the mean blood pressure change and the rate of achieving target blood pressure which has been recommended in the JSH guidelines. In addition, the drug safety and patient compliance to the treatment are also investigated.
Furthermore, in comparison of the patient characteristics between a group which achieves the target blood pressure and a group which does not, the factors affecting effectiveness of the treatment are determined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Systolic-blood-pressure change in three-month treatment.
Key secondary outcomes
1.The rate of achieving the target SBP-DBP in three-month treatment
2.DBP change in the three-month treatment
3.The SBP/DBP changes and the rates of achieving the target blood pressure at 3,6, and 12 months
4.The rate of continued treatment and the compliance of the treatment
5.Rates of adverse experiences
6.Subanalysis on patient characteristics between the groups which achieves target blood pressure and which des not
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
giving written informed consent.
The inclusion criteria for study patients
1.Patients with essential hypertension, who have been previously treated with ARB monotherapy.(Losartan 50 mg, candesartan 8 mg, valsartan 80 mg, telmisartan 40 mg, or olmesartan 20 mg) or combination of ARB and calcium channel blocker (amlodipine 5mg) for more than a month and whose blood pressure has not been adequately controlled with the treatment (SBP >140 mmHg and/or DBP >90mmHg:In the case of a diabetic, SBP >130 mmHg and/or DBP >80mmHg).
2.Patients aged 20 to 80 years at the time of the first visit.
3.Gender is not restricted.
4.Out patients
5.Patients who are able to understand study procedures and agree to participate in the study by
Key exclusion criteria
Exclusion criteria
1. Patients with the secondary hypertension
2. Patients with cardiac insufficiency (above NYHA grade III)
3.Women who are pregnant (positive urine pregnancy test at prestudy) or breast feeding, or expecting to conceive duration the study period
4. Patients with a critical liver damage
5. Patient with a history of severe hepatic or renal disease (sCr>2.0mg/dl)
6. Patients with a history of hypersensitivity to ingredients of Preminent.
7. Patients with a history of hypersensitivity to components of thiazide or similar compounds.
8. Patients who are considered to be not eligible to the study by the investigator due to medical reasons.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoaki Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
65 Tsurumai, Showa-Ku Nagoya
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Maeda |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
65 Tsurumai, Showa-Ku Nagoya
TEL
Homepage URL
Sponsor or person
Institute
Hypertension Academy in NAGOYA
Institute
Department
Personal name
Funding Source
Organization
Japan Heart foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 09 | Month | 03 | 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
| 2007 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study.
Management information
Registered date
| 2007 | Year | 09 | Month | 03 | Day |
Last modified on
| 2010 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000978
