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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00454207
Date of registration:	28/03/2007
Prospective Registration:	Yes
Primary sponsor:	Pfizer
Public title:	Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension
Scientific title:	A Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial Hypertension
Date of first enrolment:	April 2007
Target sample size:	44
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00454207
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
Japan

Contacts

Name:	Pfizer CT.gov Call Center
Address:
Telephone:
Email:
Affiliation:	Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects aged 16 and over, and classified as having pulmonary arterial hypertension

- Subjects who meet the following conditions on right heart catheterization at screening
or baseline: mean pulmonary arterial pressure of = 25mmHg and pulmonary capillary
wedge pressure of = 15mmHg at rest

- Subjects whose baseline 6-Minute Walk test distance is >100 m and <450 m

Exclusion Criteria:

- Significant Hepatic and/or renal disorder

- Subjects with known hereditary degenerative retinal disorders (such as retinitis
pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION)

- Subjects who are currently receiving nitrates or nitric oxide donors in any form,
ritonavir, ketoconazole and itraconazole

Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: sildenafil citrate (UK-92,480)

Primary Outcome(s)

Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, week 12]

Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Secondary Outcome(s)

Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II [Time Frame: Baseline, Week 12]

Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 8, Week 12]

Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320 [Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing]

Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: baseline, Week 12]

Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: baseline, Week 12]

Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 8]

Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) [Time Frame: Baseline up to 1.3 years]

Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II [Time Frame: Baseline, Week 12]

Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 4, Week 8, Week 12]

Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320 [Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing]

Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II [Time Frame: Baseline, Week 12]

Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I [Time Frame: Baseline, Week 12]

Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II [Time Frame: Baseline, Week 12]

The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320 [Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing]

The Average Plasma Concentration (Css,av) of Sildenafil at Steady State [Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing]

The Average Plasma Trough Concentration (Ctrough) of Sildenafil [Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing]

Secondary ID(s)

A1481252

JapicCTI-070381

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	09/09/2010
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00454207

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