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.

Serodus AS7 sites in 4 countries17 target enrollmentOctober 2013

ConditionsIsolated Systolic Hypertension

InterventionsSER100 Placebo

DrugsSER100 Placebo

Overview

Phase: Phase 2
Intervention: SER100
Conditions: Isolated Systolic Hypertension
Sponsor: Serodus AS
Enrollment: 17
Locations: 7
Primary Endpoint: Number of participants with adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

September 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Serodus AS

Responsible Party

Sponsor

Eligibility Criteria

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