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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000749
Receipt No. 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

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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
Email

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
Email h-tobari@umin.ac.jp

Sponsor
Institute Public Health,
Department of Social and Environmental Medicine,
Division of Preventive and Environmental Medicine,
Graduate School of Medicine,
Osaka University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000901

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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