UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000749 |
|---|---|
| Receipt number | R000000901 |
| Scientific Title | Effect of physician-and pharmacist-cooperated intervention for lowering blood pressures among hypertensive patients. |
| Date of disclosure of the study information | 2007/06/27 |
| Last modified on | 2011/02/24 13:16:33 |
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Basic information
Public title
Effect of physician-and pharmacist-cooperated intervention for lowering blood pressures among hypertensive patients.
Acronym
PaPrica study
Scientific Title
Effect of physician-and pharmacist-cooperated intervention for lowering blood pressures among hypertensive patients.
Scientific Title:Acronym
PaPrica study
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Medicine in general | Cardiology | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of pharmacist approach to hypertensive patients.
1. To determine the optimal target blood pressure level
2. To examine regression of cardiovascular risk factors
3. To compare the distribution of cessation or decrease of antihypertensive medications between control and physician- and pharmacist- cooparative group
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
1) Blood pressure at clinic and home
2) Distribution of cessation or decrease of antihypertensive medications
End point was variable change form baseline at 24 weeks.
Key secondary outcomes
1) Urinary sodium and sodium reduction score
2) Regression of cardiovascular risk factors; obesity (waist circumference and BMI), prevalence of smoking, dyslipidemia, and prevalence of heavy alcohol drinking habit
3) Serum lipid: HDL cholesterol, LDL cholesterol, triglyceride
4) Liver function: gamma-GTP
5) Renal function: urinary microalbumin, creatinine, uric acid, and BUN
6) Glucose metabolism: HbAlc
7) Life style questionnaire score, SF-36 questionnaire score, and QOL score for antihypertensive medication
8) Costs and benefits of physician-and pharmacist-cooperated intervention
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Standard medical care
Interventions/Control_2
Intensive care (with pharmacist-led health promotion)
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Patients taking antihypertensive medication.
- Untreated subjects with SBP of 140-179 mmHg and/or DBP 90-109 mmHg in a health screening or at clinic.
Key exclusion criteria
- Secondary hypertension.
- Severe renal failure or nephrotic syndrome. - Past history or under treatment of any cardiovascular disease.
- Diabetes mellitus requiring medication.
- Rheumatism or endocrine disease.
- Exercise restriction over 20-min brisk walking or cycling per a day.
- Other patients judged unsuitable for the study by physician.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Iso |
Organization
Osaka University,
Graduate School of Medicine
Division name
Public Health, Department of Social and Environmental Medicine, Division of Preventive and Environmental Medicine
Zip code
Address
2-2 Yamadaoka, Suita-shi, Osaka, 565-0871, Japan
TEL
06-6879-3911
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Tobari |
Organization
Osaka University, Graduate School of Medicine
Division name
Public Health, Department of Social and Environmental Medicine
Zip code
Address
2-2 Yamadaoka, Suita-shi, Osaka, 565-0871, Japan
TEL
06-6879-3911
Homepage URL
h-tobari@umin.ac.jp
Sponsor or person
Institute
Public Health,
Department of Social and Environmental Medicine,
Division of Preventive and Environmental Medicine,
Graduate School of Medicine,
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Public Health,
Department of Social and Environmental Medicine,
Division of Preventive and Environmental Medicine,
Graduate School of Medicine,
Osaka University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Miho Medical Clinic,
Horsemen's Benevolent Association,
Japan Racing Association
Name of secondary funder(s)
None
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
財団法人競馬共助会美浦診療所（茨城県）
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1038/ajh.2010.127
Number of participants that the trial has enrolled
Results
The 6-month follow-up rate was 97% in both groups. At 6 months, the mean decrease in SBP/DBP, as measured at home in the morning, was 2.9/3.3 mm Hg in the intervention group relative to baseline (P = 0.02 and P < 0.0001 for SBP and DBP, respectively). The mean decrease in home morning SBP in the intervention group was not significantly greater than in the control group. However, the DBP decline was significantly greater in the intervention than control groups, which showed a mean decrease of 2.8 mm Hg (confidence interval: -5.5 to -0.1; P = 0.04). The percentage of patients in whom control of home morning BP was achieved was 53% in the intervention group and 47% in the control group (P = 0.40). A higher percentage of patients in the intervention group, relative to the control group, were able to reduce the use of antihypertensive medications (31 vs. 8%, P < 0.0001), and fewer patients in this group required additional medications or increases in dosage relative to the controls (11 vs. 28%, P = 0.03). Patients of the intervention group were more likely to show reduction in body mass index and sodium intake and to stop smoking, as compared with the control group.
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 | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 06 | Month | 26 | Day |
Last modified on
| 2011 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000901
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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