Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

PAHpulmonary hypertensioncicletaninecicletanine HCLcardiovascularendothelin receptor antagonistERAmonotherapycombination therapyphosphodiesterase type-5 inhibitorPDE5iparenteral prostanoidPHpulmonary

Outcome Measures

Primary Outcomes (1)

Change from baseline in six-minute walk distance (6MWD) evaluated after 12 weeks of treatment
Baseline to Week 12

Secondary Outcomes (1)

Change from baseline in BDI, WHO Functional Class, BNP, cardiac hemodynamics and SF-36 physical functioning scale following 12 weeks of treatment. In addition, time to clinical worsening (TTCW) will be evaluated.
Baseline to Week 60

Study Arms (4)

Cicletanine 150 mg QD

EXPERIMENTAL

Cicletanine 150 mg administered once daily (QD)

Drug: Cicletanine

Cicletanine 150 mg BID

EXPERIMENTAL

Cicletanine 150 mg administered twice daily (BID)

Drug: Cicletanine

Cicletanine 300 mg QD

EXPERIMENTAL

Cicletanine 300 mg administered once daily (QD)

Drug: Cicletanine

Interventions

CicletanineDrug

Cicletanine capsules 150 mg or 300 mg administered orally once or twice daily

Cicletanine 150 mg BIDCicletanine 150 mg QDCicletanine 300 mg QDPlacebo

Cicletanine PlaceboDrug

Eligibility Criteria

Age16 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Between 16 and 70 years of age
Weigh greater than or equal to 40 kg

Sponsors & Collaborators

Gilead Sciences
Industrylead

Study Sites (56)

University of South Alabama

Mobile, Alabama, 36617, United States

Arizona Pulmonary Specialists

Phoenix, Arizona, 85013, United States

VA Greater LA Healthcare System

Los Angeles, California, 90073, United States

University of California San Diego Medical Center

San Diego, California, 92037, United States

Harish H. K. Murthy, MD

San Jose, California, 95124, United States

UCLA Medical Center

Torrance, California, 90502, United States

University of Colorado Denver

Aurora, Colorado, 80045, United States

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHypertension, Pulmonary

Interventions

cicletanine

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

Gennyne Walker, PhD
Senior Clinical Research Scientist, Gilead Sciences
STUDY CHAIR

Enrollment

162 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

January 2009

Date type not reported

This date has not been verified as actual or estimated.

Study of Cicletanine for Pulmonary Arterial Hypertension (PAH)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Cicletanine 150 mg QD

Cicletanine 150 mg BID

Cicletanine 300 mg QD

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (56)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Cicletanine 150 mg QD

Cicletanine 150 mg BID

Cicletanine 300 mg QD

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (56)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations