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Trial record 35 of 66 for:    "Lung Disease" | "Bosentan"

Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT00323297
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : November 19, 2013
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pulmonary Arterial Hypertension
Interventions Drug: Bosentan
Other: Placebo
Drug: Sildenafil Citrate
Enrollment 105
Recruitment Details This study was conducted at 29 active centers in 10 countries (10 centers in Germany, 5 centers in the United States of America [USA], 3 centers in France, 2 centers in Australia, Czech Republic, Italy, and Israel, and 1 center in Greece, Taiwan and United Kingdom [UK])
Pre-assignment Details Participants were on bosentan therapy for 3 months prior. Participants were randomized to sildenafil or placebo. Part A study was double-blind phase (12 weeks) and Part B was 12 months open-label phase. 53 and 51 participants were randomized to placebo and sildenafil arm respectively. One participant in sildenafil arm did not receive any treatment
Arm/Group Title Placebo Sildenafil
Hide Arm/Group Description

In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months.

In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months.

Period Title: Part A (Double Blind Randomized)
Started 53 50
Completed 48 43
Not Completed 5 7
Reason Not Completed
Reason unspecified             0             1
Death             0             1
Protocol Violation             1             3
Unrelated adverse event             1             0
Related and Unrelated adverse event             1             0
Related adverse event             2             2
Period Title: Part B (Open-label)
Started 48 43
Completed 39 31
Not Completed 9 12
Reason Not Completed
Death             0             1
Reason unspecified             0             1
Withdrawal by Subject             1             3
Lack of Efficacy             3             1
Adverse Event             5             5
Protocol Violation             0             1
Arm/Group Title Placebo Sildenafil Total
Hide Arm/Group Description

In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months

In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months.

Total of all reporting groups
Overall Number of Baseline Participants 53 50 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 50 participants 103 participants
56.9  (14.14) 55.2  (15.10) 56.0  (14.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 50 participants 103 participants
Female
41
  77.4%
37
  74.0%
78
  75.7%
Male
12
  22.6%
13
  26.0%
25
  24.3%
Six Minute Walk Test (6MWT)   [1] 
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 53 participants 50 participants 103 participants
350.38  (87.587) 354.44  (73.121) 352.35  (80.520)
[1]
Measure Description: 6MWT is the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.
Mean Pulmonary Artery Pressure (mPAP)  
Mean (Standard Deviation)
Unit of measure:  Millimeter(mm) of mercury(Hg)
Number Analyzed 53 participants 50 participants 103 participants
44.9  (13.33) 46.9  (12.47) 45.8  (12.89)
World Health Organization Functional Class in Participants with Pulmonary Arterial Hypertension   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 50 participants 103 participants
Class I 0 0 0
Class II 15 20 35
Class III 38 29 67
Class IV 0 1 1
[1]
Measure Description: Pulmonary Arterial Hypertension criteria for WHO Class: Class I (Participants with no limitation of physical activity); Class II (Participants with slight limitation of physical activity); Class III (Participants with marked limitation of physical activity); Class IV (Participants with inability to carry out any physical activity).
1.Primary Outcome
Title Change From Baseline in the Total Distance Walked During 6 Minute Walk Time (6MWT) at Week 12
Hide Description 6MWT is the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward (LOCF) approach. Statistical analysis was carried out on LOCF values.
Arm/Group Title Placebo Sildenafil
Hide Arm/Group Description:

In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months

In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months.

Overall Number of Participants Analyzed 53 50
Mean (Standard Deviation)
Unit of Measure: Meters
Change from baseline at Week 12 (n=46,44) 17.42  (57.270) 14.08  (63.679)
Change from baseline at Week 12 LOCF (n=53,49) 14.08  (57.557) 13.62  (60.950)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sildenafil
Comments

The estimated sample size was based upon the primary endpoint. A sample size of 51 subjects per treatment group was required to detect a difference of 30 meters between treatments with 80% power at a one‑sided significance level of 0.05, assuming a standard deviation of 60 meters.

This primary statistical analysis was carried for Week 12 data.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5802
Comments A sequential closed-testing procedure was implemented for all secondary endpoints. If no statistically significant treatment effect was found for the primary endpoint then statistical tests were not to be performed on the secondary endpoints.
Method ANCOVA
Comments The mean difference in method of estimation is the difference between Sildenafil - placebo.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.38
Confidence Interval (2-Sided) 90%
-21.843 to 17.087
Parameter Dispersion
Type: Standard Error of the mean
Value: 11.722
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Change From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Week 12 LOCF
Hide Description WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class; deterioration = increase in functional class, no change = no change in functional class.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the LOCF approach.
Arm/Group Title Placebo Sildenafil
Hide Arm/Group Description:

In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months

In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months.

Overall Number of Participants Analyzed 53 50
Measure Type: Number
Unit of Measure: Participants
Worsened 2 Classes 0 0
Worsened 1 Class 1 0
No Change 45 39
Improved 1 Class 7 10
Improved 2 Classes 0 0
Discontinued 0 0
Died 0 1
Missing 0 0
3.Secondary Outcome
Title Clinical Worsening Events
Hide Description

No survival analysis was carried out for the study due to very few events of clinical worsening. Hence, we present a summary of clinical worsening events instead.

Events of clinical worsening were categorized as (A). Death, (B). Heart/lung transplantation, (C). Hospitalization due to pulmonary arterial hypertension (PAH), and (D). Clinical deterioration of PAH requiring additional therapy.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication.
Arm/Group Title Placebo Sildenafil
Hide Arm/Group Description:

In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months

In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months.

Overall Number of Participants Analyzed 53 50
Measure Type: Number
Unit of Measure: Participants
None 51 47
(A) 0 1
(B) 0 0
(C) 2 2
(D) 0 0
4.Secondary Outcome
Title Change From Baseline in Borg Dyspnea Score at Week 12
Hide Description

Borg dyspnea scale is a 10-point scale where following scores stands for severity of dyspnea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]);

  1. (very slight);
  2. (slight breathlessness);
  3. (moderate); 4 (some what severe);

5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum]); and 10 (maximum).

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach.
Arm/Group Title Placebo Sildenafil
Hide Arm/Group Description:

In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months

In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months.

Overall Number of Participants Analyzed 53 50
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change from Baseline at Week 12 (n=46,43) 0.16  (1.637) -0.73  (1.656)
Change from Baseline at Week 12 LOCF (n=53,49) 0.24  (1.709) -0.62  (1.583)
5.Secondary Outcome
Title One Year Survival Probability From the Start of Sildenafil Treatment.
Hide Description The survival probability of all participants up to 1-year post start of Sildenafil treatment; for participants who were randomized to Sildenafil, this was the week 52 from randomization, and for participants who were originally randomized to Placebo group, this was the Week 64 from Baseline (Week 52 from Week 12, when the first dose of Sildenafil was administered to these participants). Those participants who discontinued from the study prior to 1 year after start of sildenafil were considered as censored at the time of discontinuation and those who discontinued from the study post 1-year after start of sildenafil were considered as censored at the time of 1-year post start of sildenafil.
Time Frame One year from the time of starting sildenafil
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. The participants in placebo arm have received Sildenafil on or after Week 12.
Arm/Group Title Placebo Sildenafil
Hide Arm/Group Description:

In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months

In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months.

Overall Number of Participants Analyzed 48 50
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Probability of death
0.042
(0.013 to 0.127)
0.040
(0.013 to 0.124)
6.Secondary Outcome
Title One Year Survival From the Start of Sildenafil Treatment.
Hide Description The survival status of all participants who discontinued from the study, including those participants who discontinued during the double-blind phase, was to be assessed at one year post their Week 12 visit/ End of treatment visit.
Time Frame One year from the time of starting sildenafil
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population (Full Analysis Set) consisted of all participants who had been randomly assigned to study drug and received at least one dose of study medication. Missing values were replaced according to the last observation carried forward LOCF approach. The participants in placebo arm have received Sildenafil on or after Week 12.
Arm/Group Title Placebo Sildenafil
Hide Arm/Group Description:

In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months

In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months.

Overall Number of Participants Analyzed 48 50
Measure Type: Number
Unit of Measure: Participants who died
2 2
Time Frame From the time that the participant provides informed consent through and including 28 calendar days after the last administration of the investigational product
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Placebo Sildenafil
Hide Arm/Group Description

In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months.

In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.

In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months.

All-Cause Mortality
Placebo Sildenafil
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Sildenafil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/53 (43.40%)      22/50 (44.00%)    
Blood and lymphatic system disorders     
Anaemia * 1  2/53 (3.77%)  2 1/50 (2.00%)  1
Cardiac disorders     
Acute coronary syndrome * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Right ventricular failure * 1  1/53 (1.89%)  1 3/50 (6.00%)  3
Cardiac failure * 1  1/53 (1.89%)  1 1/50 (2.00%)  1
Cardiovascular disorder * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Coronary artery disease * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Mitral valve incompetence * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Pericardial effusion * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  2/53 (3.77%)  2 0/50 (0.00%)  0
Inguinal hernia * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
General disorders     
Asthenia * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Death * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Chest discomfort * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
General physical health deterioration * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Oedema peripheral * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Immune system disorders     
Contrast media allergy * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Infections and infestations     
Bronchopneumonia * 1  1/53 (1.89%)  1 2/50 (4.00%)  2
Erysipelas * 1  2/53 (3.77%)  2 0/50 (0.00%)  0
Gastritis viral * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Abscess * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Gangrene * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Osteomyelitis * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Pneumonia * 1  2/53 (3.77%)  2 0/50 (0.00%)  0
Respiratory syncytial virus infection * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Respiratory tract infection * 1  1/53 (1.89%)  1 1/50 (2.00%)  1
Sepsis * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Urinary tract infection * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Injury, poisoning and procedural complications     
Post procedural haematoma * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Investigations     
Haemoglobin decreased * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Walking distance test abnormal * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Metabolism and nutrition disorders     
Fluid overload * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Fluid retention * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteoporosis * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Back pain * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Pain in extremity * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Rotator cuff syndrome * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Breast cancer * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Gastric cancer * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Pancreatic neoplasm * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Nervous system disorders     
Paresis * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Sciatica * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Syncope * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Psychiatric disorders     
Mania * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Reproductive system and breast disorders     
Uterine haemorrhage * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  2/53 (3.77%)  2 2/50 (4.00%)  2
Pleural effusion * 1  2/53 (3.77%)  2 0/50 (0.00%)  0
Pulmonary arterial hypertension * 1  6/53 (11.32%)  6 2/50 (4.00%)  2
Haemoptysis * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Hypoxia * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Pulmonary hypertension * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Skin and subcutaneous tissue disorders     
Skin ulcer * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Surgical and medical procedures     
Skin graft * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
Vascular disorders     
Circulatory collapse * 1  0/53 (0.00%)  0 1/50 (2.00%)  1
Hypertension * 1  1/53 (1.89%)  1 0/50 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Sildenafil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/53 (71.70%)      33/50 (66.00%)    
Blood and lymphatic system disorders     
Anaemia * 1  4/53 (7.55%)  4 2/50 (4.00%)  2
Cardiac disorders     
Palpitations * 1  3/53 (5.66%)  3 5/50 (10.00%)  5
Right ventricular failure * 1  4/53 (7.55%)  4 0/50 (0.00%)  0
Ear and labyrinth disorders     
Vertigo * 1  2/53 (3.77%)  2 5/50 (10.00%)  5
Eye disorders     
Vision blurred * 1  0/53 (0.00%)  0 3/50 (6.00%)  3
Gastrointestinal disorders     
Diarrhoea * 1  5/53 (9.43%)  5 7/50 (14.00%)  7
Nausea * 1  5/53 (9.43%)  5 1/50 (2.00%)  1
General disorders     
Oedema peripheral * 1  8/53 (15.09%)  8 7/50 (14.00%)  7
Chest pain * 1  4/53 (7.55%)  4 0/50 (0.00%)  0
Infections and infestations     
Bronchitis * 1  5/53 (9.43%)  5 5/50 (10.00%)  5
Nasopharyngitis * 1  8/53 (15.09%)  8 5/50 (10.00%)  5
Upper respiratory tract infection * 1  5/53 (9.43%)  5 2/50 (4.00%)  2
Respiratory tract infection * 1  1/53 (1.89%)  1 4/50 (8.00%)  4
Sinusitis * 1  5/53 (9.43%)  5 1/50 (2.00%)  1
Investigations     
Weight increased * 1  3/53 (5.66%)  3 0/50 (0.00%)  0
Metabolism and nutrition disorders     
Gout * 1  3/53 (5.66%)  3 0/50 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain * 1  5/53 (9.43%)  5 1/50 (2.00%)  1
Arthralgia * 1  4/53 (7.55%)  4 0/50 (0.00%)  0
Musculoskeletal chest pain * 1  3/53 (5.66%)  3 0/50 (0.00%)  0
Nervous system disorders     
Headache * 1  7/53 (13.21%)  7 7/50 (14.00%)  7
Presyncope * 1  3/53 (5.66%)  3 3/50 (6.00%)  3
Syncope * 1  3/53 (5.66%)  3 0/50 (0.00%)  0
Psychiatric disorders     
Depression * 1  0/53 (0.00%)  0 3/50 (6.00%)  3
Respiratory, thoracic and mediastinal disorders     
Pulmonary arterial hypertension * 1  4/53 (7.55%)  4 2/50 (4.00%)  2
Cough * 1  3/53 (5.66%)  3 1/50 (2.00%)  1
Dyspnoea * 1  8/53 (15.09%)  8 3/50 (6.00%)  3
Pulmonary hypertension * 1  0/53 (0.00%)  0 3/50 (6.00%)  3
Vascular disorders     
Flushing * 1  4/53 (7.55%)  4 5/50 (10.00%)  5
Hypertension * 1  3/53 (5.66%)  3 1/50 (2.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00323297     History of Changes
Other Study ID Numbers: A1481243
2006-001464-23 ( EudraCT Number )
PATHWAYS ( Other Identifier: Alias Study Number )
First Submitted: May 5, 2006
First Posted: May 9, 2006
Results First Submitted: August 23, 2013
Results First Posted: November 19, 2013
Last Update Posted: November 4, 2014