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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00738062

NCT00738062
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You took part in the earlier Droxidopa study called Protocol 302
  • You are willing and able to give written consent to participate, and understand you can leave the study at any time without it affecting your future care

Who may not be able to join:

  • You are currently taking the medications ephedrine or midodrine (you must have stopped these at least 2 days before your first study visit)
  • You are currently taking blood pressure-lowering medication (although short-acting blood pressure medication taken only at bedtime may be allowed — confirm with trial site)
  • You are currently taking tricyclic antidepressants or similar medications that affect a brain chemical called norepinephrine
  • You have changed the dose, frequency, or type of any of your regular medications within the two weeks before the study starts (not counting ephedrine or midodrine)
  • You have a history of more than moderate alcohol use
  • You have a known or suspected history of drug or substance misuse
  • You are a woman who could become pregnant and are not using an accepted form of birth control (such as an IUD, hormonal contraceptives, or double barrier methods like condoms with spermicidal gel)
  • You are a man who is sexually active with a partner who could become pregnant, and you are unwilling to use condoms during the study and for 30 days after the last dose
  • You are pregnant or breastfeeding
  • You have a known or suspected allergy to the study medication or any of its ingredients
  • You already have consistently very high blood pressure (180/110 mmHg or above when sitting down)
  • You have atrial fibrillation (an irregular heartbeat) or another significant heart rhythm problem, in the opinion of the study doctor
  • You have any other serious illness affecting your overall health, liver, heart, or kidneys
  • You have diabetes (either type — confirm with trial site)
  • You have a history of a specific type of eye condition called closed-angle glaucoma
  • You have a known or suspected cancer
  • Your blood test shows a kidney-related measure called serum creatinine is above 130 umol/L
  • You have a stomach or digestive condition that may affect how your body absorbs the study drug, in the opinion of the study doctor
  • You have significant abnormal results on a physical examination or laboratory tests, in the opinion of the study doctor
  • Your personal or family situation makes it difficult for you to participate fully, in the opinion of the study doctor
  • You have a mental health condition that could interfere with the study, such as schizophrenia, major depression, or dementia, in the opinion of the study doctor
  • You are unable or unwilling to follow the study requirements for the full duration of the trial

Important: 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.

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.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Chelsea Therapeutics
Registry
clinicaltrials_gov
Start date
1 January 2008
Est. completion
1 December 2010

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇳🇿 New Zealand 🇺🇸 United States

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

Primary endpoints

Change in Orthostatic Hypotension Questionnaire Composite Score (OHQ)

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov