NCT03488719
A Study to Examine the Effect of Tesofensine and Metoprolol on the 24-hour Mean Heart Rate
See it on ClinicalTrials.gov ↗37 people
- Phase
- PHASE1
- Paid for by
- Saniona
- Finished
- 2019-06-06
- Health conditions
- Phase 1
- Who could join
- Anyone
- Ages
- 18 Years – 60 Years
- Average age
- mean 43.9 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
- White 100% · American Indian / Alaska Native 0% · Asian 0% · Native Hawaiian / Pacific Islander 0% · Black / African American 0% · More than one race 0% · Not reported 0%
Women left out
- Age limit under 65
Older women were turned away, even though they often take this medicine.
“Maximum age: 60 Years.”
- No pregnant women
Women who were pregnant could not join.
“Subject was pregnant or lactating.”
- No breastfeeding moms
Women who were breastfeeding could not join.
“Subject was pregnant or lactating.”
- Had to use birth control
Women who couldn't or didn't want to use birth control were turned away.
“Subject was willing to adhere to the contraception requirements details.”
- No hormonal birth control
Women on the pill, patch, ring, shot, implant or hormonal IUD could not join.
“…weeks prior to admission or 5 half-lives of the drug, whichever was longer, except for the occasional use of paracetamol (up to 2 g/day) or other non-steroidal anti-inflammatory drugs (NSAIDs) and hormonal contraception for female subjects.”
- Weight limit (BMI)
Women with a higher (or lower) body weight were turned away.
“Overweight and obese subjects with a body mass index (BMI) between ≥ 27 and \< 40 kg/m2 at Screening but otherwise healthy.”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“History or presence of liver disease or liver injury, as indicated by abnormal liver function tests including:”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“History of any clinically significant cardiac arrhythmia. Subject had a corrected QT interval using Fridericia's formula (QTcF) interval \> 450 msec or 2nd or 3rd degree atrioventricular (AV) block, high-grade sinoatrial block or PQ interva…”
- No diabetes
Women with diabetes were turned away.
“…intestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic (e.g., diabetes, metabolic acidosis), urologic, pulmonary (e.g., asthma or chronic obstructive pulmonary disease), neurologic, dermatologic, psychiatric, renal, and/or…”
- No mental health conditions
Women with depression, bipolar disorder or other mental health conditions were turned away.
“…tabolic (e.g., diabetes, metabolic acidosis), urologic, pulmonary (e.g., asthma or chronic obstructive pulmonary disease), neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy as judged by the Investigator.”
- No cancer
Women with current or past cancer were turned away.
“…tabolic (e.g., diabetes, metabolic acidosis), urologic, pulmonary (e.g., asthma or chronic obstructive pulmonary disease), neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy as judged by the Investigator.”
Study titles and rules are shown in their original English.