Phase 3 Pulmonary Hypertension Trial, Terminated NCT01392495 Sponsor: Novartis Pharmaceuticals Condition: Pulmonary Hypertension
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial investigated a drug called QTI571 and enrolled 17 participants in total. Four participants received a lower dose of 200 mg, and 13 received a higher dose of 400 mg. The trial was primarily looking at unwanted or harmful events (called adverse events), serious adverse events, and deaths that occurred during the study. Secondary measures included changes in how far participants could walk in six minutes, how long it took for their condition to get worse, and how much medical care they used during the trial. The reported data shows that when it came to adverse events (any unwanted health events noted during the trial), all 4 participants in the 200 mg group and all 13 in the 400 mg group experienced at least one. For serious adverse events (those considered more significant or life-threatening), 4 out of 4 in the 200 mg group and 5 out of 13 in the 400 mg group were recorded. Deaths were reported for 2 participants in the 200 mg group and 1 in the 400 mg group. Only 1 participant out of the 17 completed the study, while 16 did not complete it; the reasons for this were not detailed in the submitted data. For the secondary outcome measures — the six-minute walk distance, time to worsening, and medical resource use — the reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of these measures, so those findings cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Pulmonary Hypertension Trial, Terminated

NCT01392495
Terminated Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must have fully completed the previous related clinical trial (called CQTI571A2102), including all final assessments at the end of that study
  • You must have met the eligibility requirements for that previous trial and must not have been removed from it for safety reasons

Who may not be able to join:

  • People whose heart is not pumping strongly enough (the heart's pumping function, called ejection fraction, is below 45%)
  • People with a very low platelet count (platelets are cells that help blood clot), specifically below a certain level that increases bleeding risk
  • People with high blood pressure that is not well controlled (top number above 160 or bottom number above 90)
  • People with an abnormal heart rhythm reading on an ECG (a specific electrical measurement of the heart called QTcF is too high — above 450 milliseconds for men or 470 milliseconds for women), unless a specific heart condition called right bundle branch block is present (confirm with trial site)

Important: Other eligibility rules not listed here may also apply, so always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Australian sites

Novartis Investigative Site, Darlinghurst, New South Wales

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 June 2011
Est. completion
1 March 2014

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇩🇪 Germany 🇮🇹 Italy 🇱🇹 Lithuania 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Patients With Adverse Events, Serious Adverse Events and Deaths

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov