A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

275

Participants

Timeline

Start Date

October 31, 2002

Study Completion Date

November 30, 2003

Conditions
Hypertension, Pulmonary
Interventions
DRUG

sildenafil

sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks

DRUG

sildenafil

sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID

DRUG

placebo

placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks

DRUG

sildenafil

sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks

Trial Locations (68)

1070

Pfizer Investigational Site, Brussels

1529

Pfizer Investigational Site, Budapest

2010

Pfizer Investigational Site, Darlinghurst

2100

Pfizer Investigational Site, Copenhagen

2193

Pfizer Investigational Site, Johannesburg

3000

Pfizer Investigational Site, Leuven

3004

Pfizer Investigational Site, Melbourne

7700

Pfizer Investigational Site, Cape Town

8900

Pfizer Investigational Site, Zalaegerszeg

10032

Pfizer Investigational Site, New York

13353

Pfizer Investigational Site, Berlin

21205

Pfizer Investigational Site, Baltimore

27710

Pfizer Investigational Site, Durham

28041

Pfizer Investigational Site, Madrid

30625

Pfizer Investigational Site, Hanover

35233

Pfizer Investigational Site, Birmingham

35294

Pfizer Investigational Site, Birmingham

35385

Pfizer Investigational Site, Giessen

35392

Pfizer Investigational Site, Giessen

37232

Pfizer Investigational Site, Nashville

40138

Pfizer Investigational Site, Bologna

48109

Pfizer Investigational Site, Ann Arbor

49100

Pfizer Investigational Site, Petah Tikva

52621

Pfizer Investigational Site, Tel Litwinsky

53215

Pfizer Investigational Site, Milwaukee

55905

Pfizer Investigational Site, Rochester

56124

Pfizer Investigational Site, Pisa

56126

Pfizer Investigational Site, Pisa

59100

Pfizer Investigational Site, Kuala Lumpur

60612

Pfizer Investigational Site, Chicago

71103

Pfizer Investigational Site, Shreveport

77030

Pfizer Investigational Site, Houston

80010

Pfizer Investigational Site, Aurora

80262

Pfizer Investigational Site, Denver

90024

Pfizer Investigational Site, Los Angeles

90033

Pfizer Investigational Site, Los Angeles

90095

Pfizer Investigational Site, Los Angeles

90502

Pfizer Investigational Site, Torrance

90509

Pfizer Investigational Site, Torrance

92037

Pfizer Investigational Site, La Jolla

Pfizer Investigational Site, San Diego

92093

Pfizer Investigational Site, La Jolla

92141

Pfizer Investigational Site, Clamart

168752

Pfizer Investigational Site, Singapore

35294-0006

Pfizer Investigational Site, Birmingham

02111

Pfizer Investigational Site, Boston

05403-900

Pfizer Investigational Site, São Paulo

140 00

Pfizer Investigational Site, Prague

140 21

Pfizer Investigational Site, Prague

04103

Pfizer Investigational Site, Leipzig

Unknown

Pfizer Investigational Site, Shatin N T

Pfizer Investigational Site, Tlalpan

Pfizer Investigational Site, Parow

1081 HV

Pfizer Investigational Site, Amsterdam

NO-0027

Pfizer Investigational Site, Oslo

40-057

Pfizer Investigational Site, Katowice

01-138

Pfizer Investigational Site, Warsaw

03-709

Pfizer Investigational Site, Warsaw

41-800

Pfizer Investigational Site, Zabrze

442-721

Pfizer Investigational Site, Suwon

08035

Pfizer Investigational Site, Barcelona

08036

Pfizer Investigational Site, Barcelona

413 45

Pfizer Investigational Site, Gothenburg

431 80

Pfizer Investigational Site, Mölndal

CB3 8RE

Pfizer Investigational Site, Papworth Everard

S10 2JF

Pfizer Investigational Site, Sheffield

G11 6NT

Pfizer Investigational Site, Glasgow

NE7 7DW

Pfizer Investigational Site, HIGH Heaton, Newcastle-upon-tyne

All Listed Sponsors
lead

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

NCT00644605 - A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension | Biotech Hunter | Biotech Hunter