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

NCT00644605 | Completed Phase 3

• 1 other identifier: A1481140
• Study Type: interventional
• Target: 275
• Locations: 23 countries
• Sites: 68

Brief Summary

To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day \[TID\]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.

Conditions

Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (1)

• Change from baseline in exercise capacity, as measured by distance walked in six minutes (6-Minute Walk test).

  Week 12

Secondary Outcomes (9)

• Change from baseline in mean pulmonary arterial pressure

  Week 12

• Time from randomisation to the first occurrence of clinical worsening (death or lung transplantation or hospitalisation due to pulmonary hypertension or initiation of prostacyclin therapy or initiation of bosentan therapy)

  Week 0 to 12

• Change from baseline in the BORG dyspnoea score

  Week 12

• Change from baseline in pulmonary hypertension criteria for functional capacity and therapeutic class

  Week 12

• Change from baseline in the 8 dimensions of SF-36 (Physical functioning, Role functioning, Bodily pain, General health, Vitality, Social functioning, Mental health and Reported health transition)

  Week 4 and Week 12

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

Drug: sildenafil

Arm 2

ACTIVE COMPARATOR

Drug: sildenafil

Arm 3

ACTIVE COMPARATOR

Drug: sildenafil

Arm 4

PLACEBO COMPARATOR

Drug: placebo

Interventions

sildenafil DRUG

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

Arm 2

placebo DRUG

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

Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Included patients had primary pulmonary arterial hypertension, pulmonary hypertension secondary to connective tissue disease, or pulmonary hypertension with surgical repair at least 5 years previously; a mean pulmonary artery pressure greater than or equal to 25 mmHg and a pulmonary artery wedge pressure of less than or equal to 15 mmHg at rest, via right heart catheterisation within 21 days prior to randomisation; and a baseline 6-Minute Walk test distance of 100 m to 450 m.

Sponsors & Collaborators

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

Study Sites (68)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35294-0006, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35294, United States

Location

Pfizer Investigational Site

La Jolla, California, 92037, United States

Location

Pfizer Investigational Site

La Jolla, California, 92093, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90024, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90033, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90095, United States

Location

Pfizer Investigational Site

San Diego, California, 92037, United States

Location

Pfizer Investigational Site

Torrance, California, 90502, United States

Location

Pfizer Investigational Site

Torrance, California, 90509, United States

Location

Pfizer Investigational Site

Aurora, Colorado, 80010, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80262, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60612, United States

Location

Pfizer Investigational Site

Shreveport, Louisiana, 71103, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21205, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02111, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Pfizer Investigational Site

Rochester, Minnesota, 55905, United States

Location

Pfizer Investigational Site

New York, New York, 10032, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27710, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53215, United States

Location

Pfizer Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

Pfizer Investigational Site

Melbourne, Victoria, 3004, Australia

Location

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

São Paulo, São Paulo, 05403-900, Brazil

Location

Pfizer Investigational Site

Prague, 140 00, Czechia

Location

Pfizer Investigational Site

Prague, 140 21, Czechia

Location

Pfizer Investigational Site

Copenhagen, 2100, Denmark

Location

Pfizer Investigational Site

Clamart, 92141, France

Location

Pfizer Investigational Site

Berlin, 13353, Germany

Location

Pfizer Investigational Site

Giessen, 35385, Germany

Location

Pfizer Investigational Site

Giessen, 35392, Germany

Location

Pfizer Investigational Site

Hanover, 30625, Germany

Location

Pfizer Investigational Site

Leipzig, 04103, Germany

Location

Pfizer Investigational Site

Shatin N T, Hong Kong

Location

Pfizer Investigational Site

Budapest, Pest County, 1529, Hungary

Location

Pfizer Investigational Site

Zalaegerszeg, Zala County, 8900, Hungary

Location

Pfizer Investigational Site

Petah Tikva, 49100, Israel

Location

Pfizer Investigational Site

Tel Litwinsky, 52621, Israel

Location

Pfizer Investigational Site

Bologna, 40138, Italy

Location

Pfizer Investigational Site

Pisa, 56124, Italy

Location

Pfizer Investigational Site

Pisa, 56126, Italy

Location

Pfizer Investigational Site

Kuala Lumpur, 59100, Malaysia

Location

Pfizer Investigational Site

Tlalpan, Mexico

Location

Pfizer Investigational Site

Amsterdam, 1081 HV, Netherlands

Location

Pfizer Investigational Site

Oslo, NO-0027, Norway

Location

Pfizer Investigational Site

Katowice, 40-057, Poland

Location

Pfizer Investigational Site

Warsaw, 01-138, Poland

Location

Pfizer Investigational Site

Warsaw, 03-709, Poland

Location

Pfizer Investigational Site

Zabrze, 41-800, Poland

Location

Pfizer Investigational Site

Singapore, 168752, Singapore

Location

Pfizer Investigational Site

Cape Town, 7700, South Africa

Location

Pfizer Investigational Site

Johannesburg, 2193, South Africa

Location

Pfizer Investigational Site

Parow, South Africa

Location

Pfizer Investigational Site

Suwon, 442-721, South Korea

Location

Pfizer Investigational Site

Barcelona, 08035, Spain

Location

Pfizer Investigational Site

Barcelona, 08036, Spain

Location

Pfizer Investigational Site

Madrid, 28041, Spain

Location

Pfizer Investigational Site

Gothenburg, 413 45, Sweden

Location

Pfizer Investigational Site

Mölndal, 431 80, Sweden

Location

Pfizer Investigational Site

Papworth Everard, Cambridgeshire, CB3 8RE, United Kingdom

Location

Pfizer Investigational Site

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Pfizer Investigational Site

Glasgow, G11 6NT, United Kingdom

Location

Pfizer Investigational Site

HIGH Heaton, Newcastle-upon-tyne, NE7 7DW, United Kingdom

Location

Related Publications (1)

• Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.

  PMID: 22354598 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: March 27, 2008
• Study Start: October 1, 2002
• Study Completion: November 1, 2003
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

NL (1); IT (3); BR (1); ES (3); AU (2); SG (1); MY (1); CZ (2); FR (1); HK (1); DK (1); BE (2); IL (2); ZA (3); KR (1); ME (1); NO (1); GB (4); US (24); HU (2); SE (2); PL (4); DE (5)