SER100 in Isolated Systolic Hypertension

Study Overview
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Brief Summary
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Isolated Systolic Hypertension (ISH)is the dominating hypertensive disease in elderly people. Much attention has recently been drawn to the strong relationship between the systolic blood pressure and cardiovascular morbidity. In previous clinical studies carried out in individuals with normal blood pressure at baseline SER100 decreased primarily the systolic blood pressure. It is hypothesized that the effect on systolic blood pressure in hypertensive patients will be larger or equal to the fall seen in normotensive patients.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study Assessing the Safety, Tolerability and Efficacy of SER100 10 mg s.c. Twice Daily for 2 Days in Patients With Isolated Systolic Hypertension Insufficiently Treated With One or More Anti-hypertensives.

Conditions
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Isolated Systolic Hypertension

Intervention / Treatment
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* Drug: SER100
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 50-80 years (both inclusive) at screening Patients must be on stable doses with one or more antihypertensives BMI <32 kg/m2 Written informed consent 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 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SER100<br>SER100 10 mg s.c. twice daily | Drug: SER100<br> <br> Drug: Placebo<br> <br> |
| Placebo Comparator: Placebo<br>Placebo administered s.c. twice daily | Drug: SER100<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure |  | Up to 4 weeks |