Completed

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.

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What is being tested

SER100

+ Placebo

Drug
Who is being recruted

Essential Hypertension+2

+ Isolated Systolic Hypertension

+ Cardiovascular Diseases

From 50 to 80 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: October 2013
See protocol details

Summary

Principal SponsorSerodus AS
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2013

Actual date on which the first participant was enrolled.

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 TitleA 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.
NCT01987284
Principal SponsorSerodus AS
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

17 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Essential HypertensionIsolated Systolic HypertensionCardiovascular DiseasesHypertensionVascular Diseases

Criteria

6 inclusion criteria required to participate
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
Show More Criteria
12 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Placebo administered s.c. twice daily

Group II

Experimental
SER100 10 mg s.c. twice daily

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

FinnMedi Oy/Valkeakoski District Hospital

Tampere, FinlandOpen FinnMedi Oy/Valkeakoski District Hospital in Google Maps
Suspended

CRST/Turku University Hospital

Turku, Finland
Suspended

Semmelweiss University Hospital

Budapest, Hungary
Suspended

Medi3 Innlandet

Hamar, Norway
Completed7 Study Centers