SER100 in Isolated Systolic Hypertension

Isolated Systolic Hypertension Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987284
• Other study ID #: SMR-2271
• Secondary ID: 2013-001227-40
• Status: Completed
• Phase: Phase 2
• First received: November 5, 2013
• Last updated: October 19, 2016
• Start date: October 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2016
• Source: Serodus ASA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFinland: Finnish Medicines AgencyHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Isolated Systolic Hypertension

Intervention

Drug:
• SER100

• Placebo

Locations

Country	Name	City	State
Finland	FinnMedi Oy/Valkeakoski District Hospital	Tampere
Finland	CRST/Turku University Hospital	Turku
Hungary	Semmelweiss University Hospital	Budapest
Norway	Medi3 Innlandet	Hamar
Norway	Ulleval University Hospital	Oslo
United Kingdom	Brighton and Sussex University Hospital	Brighton
United Kingdom	Northwick Park Hospital	Harrow	Middlesex

Sponsors (3)

Lead Sponsor	Collaborator
Serodus ASA	Smerud Medical Research International AS, The Research Council of Norway

Countries where clinical trial is conducted

Finland,  Hungary,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		Up to 4 weeks	Yes
Secondary	Change from baseline in systolic blood pressure		Up to 4 weeks	No