UMIN-CTR Clinical Trial

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

pregnancy induced hypertension

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Mie university hospital, Department of Obstetrics and Gynecology

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

三重大学病院(三重県)

Date of disclosure of the study information

2016

Year

09

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

09

Month

13

Day

Last modified on

2019

Year

03

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027686