SER100 in Isolated Systolic Hypertension

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.

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.

Study Overview

• Status: Completed
• Conditions: Isolated Systolic Hypertension
• Intervention / Treatment: Drug: Placebo; Drug: SER100

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland
    • FinnMedi Oy/Valkeakoski District Hospital
  • Turku, Finland
    • CRST/Turku University Hospital
• Hungary
  • Budapest, Hungary
    • Semmelweiss University Hospital
• Norway
  • Hamar, Norway, 2317
    • Medi3 Innlandet
  • Oslo, Norway, 0450
    • Ullevål University Hospital
• United Kingdom
  • Brighton, United Kingdom
    • Brighton and Sussex University Hospital
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • Northwick Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SER100; SER100 10 mg s.c. twice daily	Drug: Placebo; Drug: SER100
Placebo Comparator: Placebo; Placebo administered s.c. twice daily	Drug: Placebo; Drug: SER100

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Serodus ASA
• Collaborators: The Research Council of Norway; Smerud Medical Research International AS
• Investigators: Principal Investigator: Helga Gudmundsdottir, MD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimate): November 19, 2013

Study Record Updates

• Last Update Posted (Estimate): October 20, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Heart Murmurs; Hypertension; Systolic Murmurs
• Other Study ID Numbers: SMR-2271; 2013-001227-40 (EudraCT Number)