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
Public ClinicalTrials.gov record NCT00644605. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00644605
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 275 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2002
- Primary completion
- Not listed
- Completion
- Oct 31, 2003
- Last update posted
- Jan 31, 2021
2002 – 2003
United States locations
- U.S. sites
- 24
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35233 | — |
| Pfizer Investigational Site | Birmingham | Alabama | 35294-0006 | — |
| Pfizer Investigational Site | Birmingham | Alabama | 35294 | — |
| Pfizer Investigational Site | La Jolla | California | 92037 | — |
| Pfizer Investigational Site | La Jolla | California | 92093 | — |
| Pfizer Investigational Site | Los Angeles | California | 90024 | — |
| Pfizer Investigational Site | Los Angeles | California | 90033 | — |
| Pfizer Investigational Site | Los Angeles | California | 90095 | — |
| Pfizer Investigational Site | San Diego | California | 92037 | — |
| Pfizer Investigational Site | Torrance | California | 90502 | — |
| Pfizer Investigational Site | Torrance | California | 90509 | — |
| Pfizer Investigational Site | Aurora | Colorado | 80010 | — |
| Pfizer Investigational Site | Denver | Colorado | 80262 | — |
| Pfizer Investigational Site | Chicago | Illinois | 60612 | — |
| Pfizer Investigational Site | Shreveport | Louisiana | 71103 | — |
| Pfizer Investigational Site | Baltimore | Maryland | 21205 | — |
| Pfizer Investigational Site | Boston | Massachusetts | 02111 | — |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48109 | — |
| Pfizer Investigational Site | Rochester | Minnesota | 55905 | — |
| Pfizer Investigational Site | New York | New York | 10032 | — |
| Pfizer Investigational Site | Durham | North Carolina | 27710 | — |
| Pfizer Investigational Site | Nashville | Tennessee | 37232 | — |
| Pfizer Investigational Site | Houston | Texas | 77030 | — |
| Pfizer Investigational Site | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 44 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00644605, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 31, 2021 · Synced Sep 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00644605 live on ClinicalTrials.gov.