UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024042
Receipt No. R000027686
Scientific Title A multicenter phase II trial of the efficacy and safety of tadalafil with pre-eclampsia.
Date of disclosure of the study information 2016/09/15
Last modified on 2019/03/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A multicenter phase II trial of the efficacy and safety of tadalafil with pre-eclampsia.
Acronym Medication in Pre-Eclampsia Trial (MIE)II
Scientific Title A multicenter phase II trial of the efficacy and safety of tadalafil with pre-eclampsia.
Scientific Title:Acronym Medication in Pre-Eclampsia Trial (MIE)II
Region
Japan

Condition
Condition pregnancy induced hypertension
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this randomized phase II trial is to assess the efficacy and safety of tadalafil treatment on pregnancy induced hypertension.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Enrollment-to-delivery interval (days)
Key secondary outcomes 1. Completion rate of the treatment regimen.
2. Efficacy monitoring.
2.1 Incidence rate of severe preeclampsia
2.2 Incidence rate of liver dysfunction
2.3 Incidence rate of Eclampsia
2.4 Incidence rate of pulmonary edema
2.5 Incidence rate of FGR
2.6 Birth weight (g).
2.7 Gestational age at birth.
2.8 Apgar score.
2.9 Umbilical artery pH and base excess values.
2.10 Neonatal morbidity.
2.11 Offspring outcome until 1.5 years of age.
3. Safety monitoring.
3.1 Incidence rate of obstetric complications.
3.2 Perinatal mortality.
3.3 Neonatal mortality.


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Arm A: The conventional management of FGR consisted of evaluation of fetal well-being by ultrasonography including Doppler imaging and fetal heart rate monitoring to evaluate possible pregnancy termination.
Interventions/Control_2 Arm B: Oral administration of Tadalafil (20mg/day) added to the conventional management. Tadalafil treatment is continued until delivery.
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

Not applicable
Gender Female
Key inclusion criteria 1) Age>=20
2) sBP>=140 or dBP>=90 or proteinuria>=300mg/day
3) Gestational age between 20 + 0 and 33 + 6 weeks.
4) Singleton pregnancy
5) Written informed consent.
Key exclusion criteria 1)uncontrolled hypertension
2)Delivery should be attempted because of severe preeclampsia
3) A result from antepartum fetal tests consisted of ultrasonography including Doppler imaging and fetal heart rate monitoring at eligibility indicates that delivery should be attempted.
4) A history of allergy to tadalafil
5) Concurrent medications that interact adversely with tadalafil
6) Relative contraindication of tadalafil treatment due to renal disease.
7) Relative contraindication of tadalafil treatment due to liver disease.
8) Relative contraindication of tadalafil treatment due to uncontrolled arrhythmia, hypertension (BP >170/110 mmHg), and hypotension (BP <80/40 mmHg).
9) Fetus with suspected chromosomal disorder and/or multiple congenital anomalies.
10) Relative contraindication of tadalafil treatment due to retinitis pigmentosa, coagulation defect, active gastric and/or intestinal ulcer, and venous obstructive disease.
11) Attending physician decides to entry inappropriate.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoaki Ikeda
Organization Mie university hospital
Division name Department of Obstetrics & Gynecology
Zip code
Address 2-174 Edobashi Tsu-city Mie
TEL 059-232-1111
Email tadafer.study@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Michiko Kubo, Hiroaki Tanaka, Takashi Umekawa
Organization Mie University Faculty of Medicine
Division name Department of Obstetrics & Gynecology
Zip code
Address 2-174 Edobashi Tsu-city Mie
TEL 059-232-1111
Homepage URL
Email tadafer.study@gmail.com

Sponsor
Institute Mie university hospital, Department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 三重大学病院(三重県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 15 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
2016 Year 09 Month 08 Day
Date of IRB
2016 Year 08 Month 25 Day
Anticipated trial start date
2016 Year 10 Month 17 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 13 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027686

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.