![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000014135 |
Receipt No. | R000016455 |
Scientific Title | Study on the effect on bone metabolism markers of ARB combination drug that targets high blood pressure patients |
Date of disclosure of the study information | 2014/06/02 |
Last modified on | 2018/12/04 |
Basic information | ||
Public title | Study on the effect on bone metabolism markers of ARB combination drug that targets high blood pressure patients | |
Acronym | Study on the effect on bone metabolism markers of ARB combination drug that targets high blood pressure patients | |
Scientific Title | Study on the effect on bone metabolism markers of ARB combination drug that targets high blood pressure patients | |
Scientific Title:Acronym | Study on the effect on bone metabolism markers of ARB combination drug that targets high blood pressure patients | |
Region |
|
Condition | |||
Condition | Hypertension | ||
Classification by specialty |
|
||
Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Evaluation of bone metabolic effects and antihypertensive effect in combination with thiazide diuretics and losartan in elderly hypertensive patients. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Comparison of clinical and laboratory data before and after the start of combination therapy. |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | losartan, Trichlormethiazide | |
Interventions/Control_2 | losartan | |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1)Patients with age of 65 years and more.
2)Male or female. 3)Outpatient or hospitalization. 4)Hypertension; Patient uses ARB for one month or more, In hospital, patient with systolic blood pressure of 140 mmHg and more, or diastolic blood pressure of 90 mmHg and more. In home, patient with systolic blood pressure of 135 mmHg and more, or diastolic blood pressure of 85 mmHg and more. |
|||
Key exclusion criteria | 1)Patients with hypersensitivity for the study drugs.
2)Patients with bilateral renal artery stenosis. 3)Patients with hyperkalemia. 4)Patients with eGFR value of 29 mL/min/1.73m2 or less. 5)Patients who uses of corticosteroid and/or immunosuppressant. 6)Patients who are considered to be inappropriate by the investigators. |
|||
Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Saitama Medical University | ||||||
Division name | Department of Endocrinology and Diabetes | ||||||
Zip code | |||||||
Address | Morohongo 38, Moroyama, Iruma-gun, Saitama | ||||||
TEL | 049-276-1204 | ||||||
shigemitsuyasuda@msn.com |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Saitama Medical University | ||||||
Division name | Department of Endocrinology and Diabetes | ||||||
Zip code | |||||||
Address | Morohongo 38, Moroyama, Iruma-gun, Saitama | ||||||
TEL | 049-276-1204 | ||||||
Homepage URL | |||||||
shigemitsuyasuda@msn.com |
Sponsor | |
Institute | Saitama Medical University |
Institute | |
Department |
Funding Source | |
Organization | Saitama Medical University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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 |
|
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 | Terminated | ||||||
Date of protocol fixation |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016455 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |