Isolated Systolic Hypertension MedDRA version: 16.0 Level: LLT Classification code 10050591 Term: Isolated systolic hypertension System Organ Class: 100000004866
Conditions
Interventions
Product Name: SER100
Product Code: SER100
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the pl
Sponsors
Serodus ASA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Isolated Systolic Hypertension: mean systolic blood pressure = 150 mmHg and mean diastolic blood pressure =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Acute myocardial infarction in the last 6 months before screening • Stroke in the last 6 months before screening • Uncompensated heart failure (NYHA Class IV) • Angina pectoris with an anticipated need for administration of short-acting nitrates • Known, severe sleep apnoea • Abnormal laboratory values (i.e. > 2 x upper normal limit) at screening for any of o Creatinine o ALT o AST o ALP o GGT o Bilirubin • Subjects working night shifts (11 PM to 7 AM) • Participation in any other clinical trial with an investigational medicinal product or device within 1 month prior to randomisation. • Subjects with upper arm circumference =24 cm or = 42 cm. • Any general condition, serious disease or current evidence of any mental or physical disorder or collaboration attitude (e.g. dementia, substance abuse) which, in the judgment of the investigator makes the subject unsuitable for enrollment, and/or may interfere with the study evaluations or affect subject’s safety and/or may cause risk for poor protocol compliance • Pregnant or lactating women. • Female subjects of childbearing potential, or male subjects whose female partner (unless post-menopausal for 1 year or surgically sterile) is unwilling to use adequate contraceptive measures throughout the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate safety and tolerability of SER100 vs. placebo in patients with ISH;Secondary Objective: Evaluate changes in blood pressure of SER100 vs. placebo in patients with ISH;Primary end point(s): Adverse events;Timepoint(s) of evaluation of this end point: Over the duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean systolic ambulatory blood pressure • Mean diastolic ambulatory blood pressure;Timepoint(s) of evaluation of this end point: Mean day-time ABPM will be calculated based on all readings, but also in separate periods throughout the day (e.g. hours 0-1, 1-3, 3-5, 5-8 after dose 1 and 3; and hours 0-1, 1-3 after dose 2 and 4 | — |
Countries
Finland
Contacts
Public ContactClinical Trials Information
Serodus ASA
Outcome results
None listed