UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of phosphodiesterase V (sildenafil) on pulmonary arterial hypertension
Title of the study (Brief title)	Effects of sildenafil on pulmonary arterial hypertension
Region	Japan

Condition
Condition	Pulmonary arterial hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prove hemodynamic effects and safety of sildenafil in patients with pulmonary arterial hypertention
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	Decrease in pulmonary arterial pressure, pulmonary vascular resistance and increase in cardiac output at 24 weeks after allocation of patients
Key secondary outcomes	Improvement of exercise tolerance (anaerobic threshold and peak VO2) assessed by cardiopulmonary exercise testing

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatment with sildenafil 25mg three times daily for 24 weeks
Interventions/Control_2	Treatment with prior therapy without sildenafil for 24 weeks
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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients with pulmonary arterial hypertension 2. Patients in WHO functional class II-IV and with estimated right ventricular systolic pressure (transtricuspid valve pressure gradient+10)>40mmHg under prior therapy 3. Patients with informed concent
Key exclusion criteria	1. Patients with PCWP>15mmHg 2. Pregnat women or women of childbearing potential or brestfeeding 3. Patients who are being treated with medicines that contain nitrates 4. Patients who are being treated with phosphodiesterase inhibitors other than sildenafil 5. Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
Target sample size	20

Research contact person
Name of lead principal investigator	Atsushi Yao
Organization	The University of Tokyo Hospital
Division name	Division of cardiovascular internal medicine
Address	7-3-1, Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan
TEL	03-3815-5411(33076)
Email

Public contact
Name of contact person	Atsushi Yao
Organization	The University of Tokyo Hospital
Division name	Division of cardiovascular internal medicine
Address	7-3-1, Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan
TEL	03-3815-5411(33076)
Homepage URL
Email	YAOA-INT@h.u-tokyo.ac.jp

Sponsor
Institute	Division of cardiovascular internal medicine, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	Division of cardiovascular internal medicine, The University of Tokyo Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2006 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 02 Month 01 Day
Anticipated trial start date	2007 Year 01 Month 01 Day
Last follow-up date	2009 Year 12 Month 01 Day
Date of closure to data entry	2011 Year 01 Month 31 Day
Date trial data considered complete	2011 Year 01 Month 31 Day
Date analysis concluded	2011 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2006 Year 02 Month 28 Day
Last modified on	2017 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000439