UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000964 |
|---|---|
| Receipt number | R000001152 |
| Scientific Title | The Japan Home vs. Office blood pressure Measurement Evaluation with AI <J-HOME AI> Multi-center randomized controlled study on efficacy of PREMINENT (losartan 50 mg/HCTZ 12.5 mg) and high-dose Angiotensin Receptor Blockers (ARBs) on home blood pressure / clinic blood pressure / augmentation index / central blood pressure in patients with uncontrolled hypertension under moderate-dose ARB monotherapy |
| Date of disclosure of the study information | 2008/01/04 |
| Last modified on | 2009/01/05 10:46:51 |
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Basic information
Public title
The Japan Home vs. Office blood pressure Measurement Evaluation with AI
<J-HOME AI>
Multi-center randomized controlled study on efficacy of PREMINENT (losartan 50 mg/HCTZ 12.5 mg) and high-dose Angiotensin Receptor Blockers (ARBs) on home blood pressure / clinic blood pressure / augmentation index / central blood pressure in patients with uncontrolled hypertension under moderate-dose ARB monotherapy
Acronym
The Japan Home vs. Office blood pressure Measurement Evaluation with AI
<J-HOME AI>
Scientific Title
The Japan Home vs. Office blood pressure Measurement Evaluation with AI
<J-HOME AI>
Multi-center randomized controlled study on efficacy of PREMINENT (losartan 50 mg/HCTZ 12.5 mg) and high-dose Angiotensin Receptor Blockers (ARBs) on home blood pressure / clinic blood pressure / augmentation index / central blood pressure in patients with uncontrolled hypertension under moderate-dose ARB monotherapy
Scientific Title:Acronym
The Japan Home vs. Office blood pressure Measurement Evaluation with AI
<J-HOME AI>
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
- To compare the efficacy on home blood pressure and the safety between PREMINENT (losartan 50 mg/HCTZ 12.5 mg) and maximum dose of ARBs in patients with essential hypertension uncontrolled under monotherapy with moderate-dose ARB.
- To compare the effects on central blood pressure and augmentation index by using HEM-9000AI (OMRON Healthcare).
- To clarify a patient group susceptible to treatment intensification
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Evaluation of various parameters measured at home, including home blood pressure and heart rate changes, during an eight-week treatment.
Key secondary outcomes
- Clinic blood pressure, augmentation index, central blood pressure change in eight-week treatment.
- Rate of achieving the target clinic blood pressure and home blood pressure at eight-week treatment.
- Change in laboratory test results including LDL-C, K, sCr, uric acid, blood sugar, and HbA1c.
- Safety of PREMINENT and maximum dose of ARBs
- Sub-analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
- Titration to high-dose ARBs (losartan 100mg, candesartan 12mg, valsartan 160mg, telmisartan 80mg, olmesartan 40mg)
- Once daily
- Treatment period: 8 weeks
Interventions/Control_2
- Change to Preminent (losartan 50mg/HCTZ 12.5mg)
- Once daily
- Treatment period: 8 weeks
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria for study patients:
1) Out-patient with essential hypertension, who has been previously treated with moderate-dose ARB monotherapy and whose blood pressure has not been adequately controlled with the treatment
- Patient has received one of five ARB monotherapies (either Losartan 50 mg, Candesartan 8 mg, Valsartan 80 mg, Telmisartan 40 mg, or Olmesartan 20 mg) at least for 4 weeks.
- Untreated patient at -4 weeks, with a clinic SBP >=140 mmHg and/or DBP >90mmHg
- Average home morning SBP >=135 mmHg at 0 week
2) Between 20 and 80 years of age
3) Gender is not restricted.
4) Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study.
Key exclusion criteria
Exclusion criteria
1) Secondary hypertension
2) Cardiac failure (above NYHA grade III)
3) Past history of major cardiac events or intervention (e.g., myocardial infarction, stroke) within 6 months prior to the start of the study.
4) Pregnancy (positive urine pregnancy test at pre-study) or breast feeding, or a female expecting to conceive within the study.
5) Critical liver damage
6) History of severe hepatic or renal disease (sCr>2.0 mg/dl)
7) Uncontrollable arrhythmia (atrial fibrillation, etc)
8) Hypersensitivity to ARB
9) Hypersensitivity to components of thiazide or similar compounds
10)Patient ineligible to this study due to other medical reasons
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Imai |
Organization
Tohoku University Graduate School
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
6-3 Aoba, Aramaki, Aoba-ku, Sendai 980-8578, JAPAN
TEL
022-795-6807
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichiro Hashimoto |
Organization
Tohoku University Graduate School
Division name
Department of Planning for Drug Development and Clinical Evaluation
Zip code
Address
6-3 Aoba, Aramaki, Aoba-ku, Sendai 980-8578, JAPAN
TEL
022-795-6843
Homepage URL
jhashimoto@mail.tains.tohoku.ac.jp
Sponsor or person
Institute
J-HOME AI Study group
Institute
Department
Personal name
Funding Source
Organization
Miyagi Kidney foundation
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
| 2008 | Year | 01 | Month | 04 | 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 | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 04 | Day |
Last modified on
| 2009 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001152
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| Registered date | File name |
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