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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000011959 |
Receipt No. | R000013971 |
Scientific Title | The effect of losartan/hydrochlorothiazide combination therapy on LV diastolic function in patients with uncontrolled hypertension in comparison with a high-dose losartan therapy |
Date of disclosure of the study information | 2013/10/04 |
Last modified on | 2013/10/04 |
Basic information | ||
Public title | The effect of losartan/hydrochlorothiazide combination therapy on LV diastolic function
in patients with uncontrolled hypertension in comparison with a high-dose losartan therapy |
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Acronym | The effect of losartan/hydrochlorothiazide combination therapy on LV diastolic function in patients with hypertension | |
Scientific Title | The effect of losartan/hydrochlorothiazide combination therapy on LV diastolic function
in patients with uncontrolled hypertension in comparison with a high-dose losartan therapy |
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Scientific Title:Acronym | The effect of losartan/hydrochlorothiazide combination therapy on LV diastolic function in patients with hypertension | |
Region |
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Condition | ||
Condition | hypertension | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effects of the combination therapy of losartan and hydrochlorothiazide on LV diastolic function compared with high-dose losartan therapy in patients with uncontrolled hypertension |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase IV |
Assessment | |
Primary outcomes | E/E' in echocardiography, BNP |
Key secondary outcomes | MMP-2, MMP-9, TIMP-1, TIMP-2 |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Numbered container method |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | losartan (50mg/day) + HCTZ (12.5mg/day) | |
Interventions/Control_2 | losartan (100mg/day) | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | uncontrolled hypertensive patients (BP>140/90 mmHg) treated by losartan (50mg/day) with LV diastolic dysfunction (15<=E/E' OR 8<=E/E'<15 & 200<BNP) | |||
Key exclusion criteria | LV systolic dysfunction (EF<50%)
liver dysfunction (AST or ALT>=100) renal dysfunction (eGFR<30) |
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Target sample size | 36 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tottori University Hospital | ||||||
Division name | Division of Clinical Laboratory | ||||||
Zip code | |||||||
Address | 36-1 Nishicho, Yonago 683-8504, Japan | ||||||
TEL | 0859-38-6792 | ||||||
ko-36@umin.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tottori University Hospital | ||||||
Division name | Division of Clinical Laboratory | ||||||
Zip code | |||||||
Address | 36-1 Nishicho, Yonago 683-8504, Japan | ||||||
TEL | 0859-38-6792 | ||||||
Homepage URL | |||||||
ko-36@umin.ac.jp |
Sponsor | |
Institute | Tottori University Hospital |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Education, Culture, Sports, Science and Technology |
Organization | |
Division | |
Category of Funding Organization | |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 | 鳥取大学医学部附属病院(鳥取県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | The combination therapy decreased BNP level, however, the high-dose losartan therapy did not.
The combination therapy decreased E/E', however, the high-dose therapy did not. The combination therapy decreased MMP-2 level, however, the high-dose therapy did not. |
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 |
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Date of IRB | |||||||
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013971 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |