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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000001350
Date of registration:	01/10/2008
Prospective Registration:	No
Primary sponsor:	Keio University
Public title:	Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases
Scientific title:	Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases - Keio university clinical trial for early pulmonary arterial hypertension with connective tissue diseases (KEEP-ACTIVE study)
Date of first enrolment:	2008/09/01
Target sample size:	70
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001589
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Masataka Kuwana
Address:	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN Japan
Telephone:	03-3353-1211
Email:	kuwanam@z5.keio.jp
Affiliation:	Department of Internal Medicine, Keio University School of Medicine Division of Rheumatology

Name:	Hidekata Yasuoka
Address:	35 Shinanomachi, Shinjuku, Tokyo, Japan Japan
Telephone:	03-3353-1211
Email:	yasuokah@z8.keio.jp
Affiliation:	Department of Internal Medicine, Keio University School of Medicine Division of Rheumatology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Hypersensitivity to Sildenafil or Beraprost. 2) Patients with chronic pulmonary thromboembolism. 3) Patients who will be on home oxygen therapy 4) Patients who will be classified as WHO class III or IV 5) Patients with severe ischemic heart diseases or cardiomyopathy 6) Patients with malignancy

Age minimum: 18years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Pulmonary arterial hypertension (PAH) associated with connective tissue disease

Intervention(s)

Beraprost sodium
Beraprost sodium and Sildenafil citrate

Primary Outcome(s)

Time to clinical worsening

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

KEEP-ACTIVE study group

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:	31/03/2018
URL:

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