Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT00654966
Eligibility Criteria:
Inclusion Criteria:
* Confirmed written informed consent.
* Male/Female over 18 and under 80 years of age.
* Females must be non-pregnant, non-lactating and using reliable means of contraception (surgical sterilisation or a barrier method such as a condom). The oral contraceptive pill is an exclusion to this study.
* Patients with CHF will be required to have left ventricular fractional shortening \[LVFS\] of \<22% or LVEF \< 40% and New York Heart Association functional class \[NYHA FC\] II-III symptoms
* Body mass index (BMI) between 18-35 kg/m2.
* Screening clinical laboratory tests including liver function tests and HbA1c are within the normal reference range for the investigative site.
* Electrocardiogram (ECG) results considered within normal limits, as determined by the Investigator.
Exclusion Criteria:
* Smokers
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological, or other disorders capable of altering the absorption, metabolism, or elimination of drugs, or of constituting a risk factor when exposed to the study medication.
* Those requiring concomitant medications that will affect cardiovascular or endothelial function or blood pressure control (eg cholesterol lowering medication, hormone replacement therapy, aspirin, NSAIDS).
* Patients receiving Hormone Replacement Therapy.
* Known allergy or hypersensitivity to urotensin or urotensin receptor antagonists or its excipients, or related drugs, or a history of relevant adverse drug reactions of any origin.
* Regular alcohol intake greater than 14 units/week or is unwilling to comply with the alcohol prohibition for the duration of the study (1 unit of alcohol is equivalent to: 12 ounces of beer, 4 ounces of wine, or 1 ounce of 50-proof hard liquor).
* History of drug abuse.
* Screening biochemistry \> 20 % outside normal limits.
* Patients who are thought to be terminally ill or immuno-compromised
* Patients who have previously been enrolled in this study or have received other experimental medications in the last 4 weeks.
* Patients who are unlikely to comply with study procedures
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00654966
Study Brief:
Protocol Section:
NCT00654966