Trial · NCT00540436
Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension
NCT00540436, Phase 2, Completed, GlaxoSmithKline; results first posted 2009-11-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension. Trials, record NCT00540436. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00540436
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension
- NCT number
- NCT00540436
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypertension, Pulmonary
- Interventions
- GSK1325760A
- First posted
- 2007-10-08
- Last updated
- 2012-10-15
- Results first posted
- 2009-11-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12 | Baseline and Week 12 | Mean change from baseline was calculated as the Week 12 value minus the baseline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes. |
| Secondary | Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal | Baseline and Week 24/Withdrawal | Change from baseline was calculated as the Week 24/Withdrawal value minus the basline value. 6MWD was measured by a 6 minute walk test. This test measures the distance that a subject can walk in a period of 6 minutes. Imputation technique was last observation carried forward. |
| Secondary | Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24 | Baseline and Weeks 12 and 24 | The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). Change from baseline was calculated as the Week 12 and 24 values minus the baseline values. The BDI indicates the degree of breathlessness after completion of the 6 minute walk test. The BDI scale was assessed by each participant. Imputation technique was last observation carried forward. |
| Secondary | Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Weeks 12 and 24 | There are four grades for WHO FC (class I = none, Class IV = most severe). The WHO FC indicates the severity of Pulmonary Arterial Hypertension and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. Imputation technique was last observation carried forward. |
| Secondary | Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) at Week 24, Assessed as the First Occurrence of a Particular Event | Week 24 | Time to clinical worsening is defined as the time from baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy, or study discontinuation due to change to other PAH treatment. Time to clinical worsening is measured as the number of participants who experienced these events during 24 weeks. |
| Secondary | Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24 | Baseline and Weeks 12 and 24 | mPAP and mRAP are measures of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques). |
| Secondary | Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24 | Baseline and Weeks 12 and 24 | CI is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques). |
| Secondary | Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24 | Baseline and Weeks 12 and 24 | CO is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques). |
| Secondary | Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24 | Baseline and Weeks 12 and 24 | PVR is a measure of cardiopulmonary hemodynamics. Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. Observed data analysis (no imputation techniques). |
| Secondary | Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24 | Baseline and Weeks 12 and 24 | Change from baseline was calculated as the Week 12 and 24 values minus the baseline value. BNP is a surrogate maker of heart failure and was measured by a central laboratory. Observed data analysis (no imputation techniques). |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12 | Baseline and Week 12 | Full Analysis Set (FAS): all participants registered, with the exception of those who had not received any dose of the investigational product and those who had no efficacy assessment after administration of the investigational product. Imputation technique was last observation carried forward. | Meters | MEAN |
| SECONDARY | Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal | Baseline and Week 24/Withdrawal | Full Analysis Set | Meters | MEDIAN |
| SECONDARY | Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24 | Baseline and Weeks 12 and 24 | Full Analysis Set | Points on a scale | MEAN |
| SECONDARY | Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Weeks 12 and 24 | Full Analysis Set | Participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) at Week 24, Assessed as the First Occurrence of a Particular Event | Week 24 | Full Analysis Set: : all participants registered, with the exception of those who had not received any dose of the investigational product and those who had no efficacy assessment after administration of the investigational product | Participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Mean Pulmonary Atery Pressure (mPAP) and Mean Right Atrial Pressure (mRAP) at Weeks 12 and 24 | Baseline and Weeks 12 and 24 | Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study. | mmHg | MEAN |
| SECONDARY | Mean Change From Baseline in Cardiac Index (CI) at Weeks 12 and 24 | Baseline and Weeks 12 and 24 | Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study. | L/min/m2 | MEAN |
| SECONDARY | Mean Change From Baseline in Cardiac Output (CO) at Weeks 12 and 24 | Baseline and Weeks 12 and 24 | Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study. | L/min | MEAN |
| SECONDARY | Mean Change From Baseline in Pulmonary Vascular Resistance (PVR) at Weeks 12 and 24 | Baseline and Weeks 12 and 24 | Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study. | mmHg/L/min | MEAN |
| SECONDARY | Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 12 and 24 | Baseline and Weeks 12 and 24 | Full Analysis Set: Analysis was conducted using observed data only. Some participants were withdrawn before Week 24, or some participants could not be measured at Week 24 in this study. | Nanograms/Liter (ng/L) | MEAN |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 12 | GSK1325760A | 33.49 | Standard Deviation 43.236 | Meters | |
| Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24/Withdrawal | GSK1325760A | 46.82 | Standard Deviation 52.705 | Meters | |
| Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24 | GSK1325760A | Week 12 | -0.60 | Standard Deviation 2.157 | Points on a scale |
| Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24 | GSK1325760A | Week 24 | -0.69 | Standard Deviation 1.904 | Points on a scale |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | GSK1325760A | Improved at Week 12 | 9 | Participants | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | GSK1325760A | No change at Week 12 | 16 | Participants | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | GSK1325760A | Deteriorated at Week 12 | 0 | Participants | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | GSK1325760A | Improved at Week 24 | 10 | Participants | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | GSK1325760A | No change at Week 24 | 14 | Participants | |
| Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | GSK1325760A | Deteriorated at Week 24 | 1 | Participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First 12-Week Treatment Period | STARTED | GSK1325760A | 25 | |
| First 12-Week Treatment Period | COMPLETED | GSK1325760A | 22 | |
| First 12-Week Treatment Period | NOT COMPLETED | GSK1325760A | 3 | |
| Second 12-Week Treatment Period | STARTED | GSK1325760A | 22 | |
| Second 12-Week Treatment Period | COMPLETED | GSK1325760A | 21 | |
| Second 12-Week Treatment Period | NOT COMPLETED | GSK1325760A | 1 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | GSK1325760A | 10 | 25 | |
| other | Nasopharyngitis | Infections and infestations | GSK1325760A | 7 | 25 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | GSK1325760A | 5 | 25 | |
| other | Hot flush | Vascular disorders | GSK1325760A | 4 | 25 | |
| other | Edema peripheral | General disorders | GSK1325760A | 4 | 25 | |
| other | Anemia | Blood and lymphatic system disorders | GSK1325760A | 3 | 25 | |
| other | Dizziness | Nervous system disorders | GSK1325760A | 3 | 25 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | GSK1325760A | 3 | 25 | |
| other | Flushing | Vascular disorders | GSK1325760A | 3 | 25 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | GSK1325760A | 3 | 25 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK1325760A | ||
| Total, other adverse events | GSK1325760A | 24 | |
| Total, serious adverse events | GSK1325760A | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21812736 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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