A study assessing the safety, tolerability and efficacy of a new medication (SER100) in patients with Isolated Systolic Hypertension (ISH) insufficiently treated with 1-3 other anti-hypertensives.

Conditions: Isolated Systolic Hypertension
MedDRA version: 14.1Level: LLTClassification code 10050591Term: Isolated systolic hypertensionSystem Organ Class: 100000004866
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-001227-40-HU

Lead Sponsor: Serodus ASA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

• Isolated Systolic Hypertension: mean systolic blood pressure = 150 mmHg and mean diastolic blood pressure < 90 mmHg – as determined by daytime continuous ambulatory blood pressure measurement (ABPM)
• Male or female
• Age 55-80 years (both inclusive) at screening
• Patients must be treated with 1-3 antihypertensives on unchanged doses for at least 30 days prior to screening visit. Intake of the underlying 1-3 anti-hypertensives must be witnessed by clinic staff prior to the qualifying ABPM.
• BMI <32 kg/m2
• Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): • Mean systolic ambulatory blood pressure<br>• 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