NCT01493557
A Prospective, Open Label Study Evaluating Two Management Strategies on Gastrointestinal Symptoms in Patients Newly on Treatment With Pradaxa for the Prevention of Stroke and Systemic Embolism With Non-valvular Atrial Fibrillation
See it on ClinicalTrials.gov ↗1,067 people
32.4%
67.6%
346 womenmiddle line = equal numbers721 men
- Phase
- PHASE4
- Paid for by
- Boehringer Ingelheim
- Finished
- 2014-07
- Health conditions
- Atrial Fibrillation
- Who could join
- Anyone
- Ages
- 18 Years – no maximum
- Average age
- mean 69.7 Years
- Age 65+
- Not reported
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- Not reported
Women left out
- No pregnant women
Women who were pregnant could not join.
“…ion less than or equal to 1 year prior to informed consent) who: are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughou…”
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“…r are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transd…”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“Creatinine clearance \<15ml/min (in Canada, \<30ml/min), or patients on renal replacement therapy (dialysis)”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“Contraindication in patients with mechanical heart valves. The use of Pradaxa in the setting of other forms of valvular heart disease, including the presence of a bio-prosthetic valve, is not recommended.”
Study titles and rules are shown in their original English.