Pulmonary HypertensionPhase 3NCT00190333
Serotonin Transporter Inhibitor Escitalopram in Pulmonary Hypertension
A Phase 3 study testing escitalopram in people with Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 9 sites in France.
Trial summary
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of escitalopram (30 mg/day) in two parallel groups (randomization ratio, escitalopram 2/placebo 1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 9 sitesFrance
- Study dates
- Jun 2005to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet all the criteria listed below will be considered for study inclusion:
- Male or female older than 18 years of age
- Meeting World Health Organization (WHO) criteria for pulmonary hypertension (mean pulmonary arterial pressure [PAP] > 25 mmHg at rest and pulmonary capillary wedge pressure < 15 mmHg during right heart catheterization):
- primary pulmonary hypertension (sporadic or familial), or
- pulmonary hypertension associated with connective tissue diseases, or
- pulmonary hypertension associated with HIV infection, or
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- pulmonary hypertension associated with use of appetite suppressants or other toxic compounds, or
- pulmonary hypertension associated with shunting through a congenital heart defect surgically treated
- Class II or III in the NYHA classification scheme
- With a 6-minute walking test distance between 40% and 80% of theoretical values (approximately 50 and 480 m)
- On conventional treatment, with no change in this treatment during the last month preceding the study. Conventional treatment includes calcium antagonists or beraprost.
- Subject who consents to participate in the study.
Who cannot join
- Subjects with any of the following clinical features will not be included in the study:
- Pulmonary hypertension related to aortic or mitral valve disease, or extrinsic pulmonary vein compression
- Pulmonary hypertension related to hypoxia from respiratory disease with a total lung capacity < 70% or Tiffeneau index < 60% upon testing within the last 6 months (chronic obstructive lung disease, interstitial disease, sleep apnea syndrome, alveolar hypoventilation, chronic exposure to high altitudes, neonatal lung disease, or alveolar capillary dysplasia)
- Pulmonary hypertension associated with portal hypertension
- Pulmonary hypertension secondary to chronic thrombosis and/or embolism (occlusion of the proximal or distal pulmonary arteries by thrombosis)
- In the 6-minute walking test, inability to walk for 6 minutes, for any reason, or walking distance of less than 50 m
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- Pregnancy, lactation, women of childbearing potential (if needed, effective contraception will be prescribed)
- History of hypersensitivity to citalopram or to medications structurally related to citalopram
- Treatment with another investigational drug within the 3 months preceding study inclusion
- Cardiovascular, hepatic, neurological or endocrine disease that is clinically significant, or any other significant disease that may interfere with the study protocol or with the interpretation of study findings
- History of drug or alcohol abuse
- Liver failure (except abnormalities related to the right ventricular failure)
- Kidney failure
- Mental status preventing the patient from understanding the nature, objectives, and possible consequences of the study
- Non stabilized psychiatric disorders
- Subject unable to comply with protocol-related constraints (e.g., uncooperative, unable to attend follow-up visits, and probably unable to complete the study).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Louis Pradel Hospital
Bron, 69677
Antoine Beclere Hospital
Clamart, 92140
Henri Mondor Hospital
Créteil, 94010
Michallon Hospital
Grenoble, 38043
Sainte Marguerite Hospital
Marseille, 13009
Haut Lévèque Hospital
Pessac, 33604
Hautepierre Hospital
Strasbourg, 67200
Rangueil Hospital
Toulouse, 31059
Brabois Hospital
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Evaluation of the Therapeutic Effects of Escitalopram in Pulmonary Hypertension, Either Primary or Associated
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of escitalopram (30 mg/day) in two parallel groups (randomization ratio, escitalopram 2/placebo 1).
Read the detailed description
Primary objective: to evaluate the efficacy of oral escitalopram at the dosage of 30 mg/day for 16 weeks on the 6-minute walking test in patients with pulmonary hypertension.
- Conditions
- Pulmonary Hypertension
- Being tested
- escitalopram
- Keywords
- pulmonary hypertension, 6 minutes walking test, serotonin, primary or associated pulmonary hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
escitalopram
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of oral escitalopram at the dosage of 30 mg/day on the 6-minute walking test in patients with pulmonary hypertension
Measured: for 16 weeks
Secondary outcomes (6)
To evaluate the efficacy of escitalopram in improving hemodynamic parameters (right heart catheterization; decision of doing right heart catheterization belonging to the investigators)
Measured: after 16 weeks
To evaluate the efficacy of escitalopram in improving the New York Heart Association (NYHA) class
Measured: after 16 weeks
To evaluate the efficacy of escitalopram in improving the dyspnea (visual analog scale)
Measured: after 16 weeks
To evaluate the efficacy of escitalopram in improving the quality of life
Measured: after 16 weeks
To evaluate the efficacy of escitalopram in reducing exacerbations of signs or symptoms of the disease that would otherwise require hospital admission or treatment intensification, particularly treatment with bosentan or IV administration of epoprostenol
Measured: after 16 weeks
To evaluate the safety of escitalopram, alone or on top of associated drugs
Measured: after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Gerald SIMONNEAU, MD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190333
- Sponsor's protocol ID
- P020305
- Status last verified
- Mar 2007
- First submitted
- 13 Sep 2005
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Therapeutic Effects of Escitalopram in Pulmonary Hypertension, Either Primary or Associated
- ClinicalTrials.gov ID
- NCT00190333
- Acronym / sponsor ID
- P020305
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, 6 minutes walking test, serotonin, primary or associated pulmonary hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of escitalopram (30 mg/day) in two parallel groups (randomization ratio, escitalopram 2/placebo 1).
Detailed description
Primary objective: to evaluate the efficacy of oral escitalopram at the dosage of 30 mg/day for 16 weeks on the 6-minute walking test in patients with pulmonary hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: escitalopram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female older than 18 years of age
- Meeting World Health Organization (WHO) criteria for pulmonary hypertension (mean pulmonary arterial pressure [PAP] > 25 mmHg at rest and pulmonary capillary wedge pressure < 15 mmHg during right heart catheterization):
- Class II or III in the NYHA classification scheme
- With a 6-minute walking test distance between 40% and 80% of theoretical values (approximately 50 and 480 m)
- On conventional treatment, with no change in this treatment during the last month preceding the study. Conventional treatment includes calcium antagonists or beraprost.
Key exclusion criteria (16 listed)
- Pulmonary hypertension related to aortic or mitral valve disease, or extrinsic pulmonary vein compression
- Pulmonary hypertension related to hypoxia from respiratory disease with a total lung capacity < 70% or Tiffeneau index < 60% upon testing within the last 6 months (chronic obstructive lung disease, interstitial disease, sleep apnea syndrome, alveolar hypoventilation, chronic exposure to high altitudes, neonatal lung disease, or alveolar capillary dysplasia)
- Pulmonary hypertension associated with portal hypertension
- Pulmonary hypertension secondary to chronic thrombosis and/or embolism (occlusion of the proximal or distal pulmonary arteries by thrombosis)
- In the 6-minute walking test, inability to walk for 6 minutes, for any reason, or walking distance of less than 50 m
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| escitalopramescitalopram | Drug | A |
Primary outcome
To evaluate the efficacy of oral escitalopram at the dosage of 30 mg/day on the 6-minute walking test in patients with pulmonary hypertension
Time frame: for 16 weeks
6 secondary outcomes
To evaluate the efficacy of escitalopram in improving hemodynamic parameters (right heart catheterization; decision of doing right heart catheterization belonging to the investigators)
Time frame: after 16 weeks
To evaluate the efficacy of escitalopram in improving the New York Heart Association (NYHA) class
Time frame: after 16 weeks
To evaluate the efficacy of escitalopram in improving the dyspnea (visual analog scale)
Time frame: after 16 weeks
To evaluate the efficacy of escitalopram in improving the quality of life
Time frame: after 16 weeks
To evaluate the efficacy of escitalopram in reducing exacerbations of signs or symptoms of the disease that would otherwise require hospital admission or treatment intensification, particularly treatment with bosentan or IV administration of epoprostenol
Time frame: after 16 weeks
To evaluate the safety of escitalopram, alone or on top of associated drugs
Time frame: after 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald SIMONNEAU, MD study chair
Assistance Publique - Hôpitaux de Paris
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing escitalopram in people with Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of oral escitalopram at the dosage of 30 mg/day on the 6-minute walking test in patients with pulmonary hypertension (time frame: for 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2011.