Pulmonary EdemaNCT01060969
Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention
A study testing Tadalafil and acetazolamide and Acetazolamide in people with Pulmonary Edema and Cerebral Edema, run by Sheba Medical Center at 3 sites in Israel.
Trial summary
To evaluate the additive value of tadalafil given together with Diamox (acetazolamide) in preventing acute mountain sickness in travelers to high altitude areas. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Edema, Cerebral Edema
- What is being tested?
- Tadalafil and acetazolamide and Acetazolamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 3 sitesIsrael
- Study dates
- Jan 2006to Aug 2010
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant in trekking to high altitude
- Agreement to sign the informed consent.
Who cannot join
- No agreement to sign informed consent.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Center of Geographic Medicine
Tel HaShomer
Sheba Medical Ctr.
Tel HaShomer
Study site
Tel HaShomer
About this study
To evaluate the additive value of tadalafil given together with Diamox (acetazolamide) in preventing acute mountain sickness in travelers to high altitude areas.
Read the detailed description
A randomized controlled study comparing:
Tadalafil [20mg x1/day] and acetazolamide [125mg x2 day], versus Acetazolamide [125mg x2 day] alone, in trekkers to altitude > 3,000 m.
- Conditions
- Pulmonary Edema, Cerebral Edema
- Being tested
- Tadalafil and acetazolamide, Acetazolamide
- Keywords
- Acute Mountain Sickness, travellers, Acetazolamide, Tadalafil, Acute Mountain Sickness assessed by Lake Louise score, High altitude pulmonary edema, High altitude cerebral edema
- Medical subject headings
- Pulmonary Edema, Brain Edema, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil and acetazolamideDrug
Experimental arm: Tadalafil 20 mg daily + acetazolamide 125 mg BID beginning above 3000 m altitude.
AcetazolamideDrug
Active comparator arm (control): acetazolamide 125 mg BID beginning above 3000 m altitude
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Active comparator | acetazolamide 125 mg BID Receives: Drug: Acetazolamide |
| Acetazolamide and Tadalafil | Experimental | Intervention arm Receives: Drug: Tadalafil and acetazolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results will be evaluated by using the Lake Louise AMS scoring system
Measured: one month after travel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJan 2006
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Eli Schwartz MD, DTMH, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060969
- Sponsor's protocol ID
- SHEBA-07-3977-ES-CTIL
- Status last verified
- Sep 2012
- First submitted
- 3 Nov 2008
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Leshem E, Caine Y, Rosenberg E, Maaravi Y, Hermesh H, Schwartz E. Tadalafil and acetazolamide versus acetazolamide for the prevention of severe high-altitude illness. J Travel Med. 2012 Sep-Oct;19(5):308-10. doi: 10.1111/j.1708-8305.2012.00636.x. Epub 2012 Jul 30.
PubMed 22943271
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention
- ClinicalTrials.gov ID
- NCT01060969
- Acronym / sponsor ID
- SHEBA-07-3977-ES-CTIL
- Conditions
- Pulmonary Edema, Cerebral Edema
- Keywords
- Acute Mountain Sickness, travellers, Acetazolamide, Tadalafil, Acute Mountain Sickness assessed by Lake Louise score, High altitude pulmonary edema, High altitude cerebral edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Feb 2010 (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.
To evaluate the additive value of tadalafil given together with Diamox (acetazolamide) in preventing acute mountain sickness in travelers to high altitude areas.
Detailed description
A randomized controlled study comparing:
Tadalafil [20mg x1/day] and acetazolamide [125mg x2 day], versus Acetazolamide [125mg x2 day] alone, in trekkers to altitude > 3,000 m.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Active comparator | Drug: Acetazolamideacetazolamide 125 mg BID |
| Acetazolamide and Tadalafil | Experimental | Drug: Tadalafil and acetazolamideIntervention arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant in trekking to high altitude
- Agreement to sign the informed consent.
Key exclusion criteria (1 listed)
- No agreement to sign informed consent.
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 |
|---|---|---|
| Tadalafil and acetazolamideExperimental arm: Tadalafil 20 mg daily + acetazolamide 125 mg BID beginning above 3000 m altitude. | Drug | Acetazolamide and Tadalafil |
| AcetazolamideActive comparator arm (control): acetazolamide 125 mg BID beginning above 3000 m altitude | Drug | Acetazolamide |
Primary outcome
Results will be evaluated by using the Lake Louise AMS scoring system
Time frame: one month after travel
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 10 Sep 2012.
- Results publication: PubMed 22943271Leshem E, Caine Y, Rosenberg E, Maaravi Y, Hermesh H, Schwartz E. Tadalafil and acetazolamide versus acetazolamide for the prevention of severe high-altitude illness. J Travel Med. 2012 Sep-Oct;19(5):308-10. doi: 10.1111/j.1708-8305.2012.00636.x. Epub 2012 Jul 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tadalafil and acetazolamide and Acetazolamide in people with Pulmonary Edema and Cerebral Edema, run by Sheba Medical Center at 3 sites in Israel.
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 2 inclusion and 1 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 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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.
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?
Results will be evaluated by using the Lake Louise AMS scoring system (time frame: one month after travel). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01060969, which also lists 1 linked publication.
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 10 Sep 2012.