Isolated Systolic HypertensionPhase 2NCT01987284
SER100 in Isolated Systolic Hypertension
A Phase 2 study testing SER100 in people with Isolated Systolic Hypertension, run by Serodus AS at 7 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Isolated Systolic Hypertension
- What is being tested?
- SER100
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Oct 2013to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Finland2 sites
FinnMedi Oy/Valkeakoski District Hospital
Tampere
CRST/Turku University Hospital
Turku
Norway2 sites
Medi3 Innlandet
Hamar, 2317
Ulleval University Hospital
Oslo, 0450
United Kingdom2 sites
Brighton and Sussex University Hospital
Brighton
Northwick Park Hospital
Harrow, Middlesex, HA1 3UJ
About this study
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.
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.
- Conditions
- Isolated Systolic Hypertension
- Being tested
- SER100, Placebo
- Medical subject headings
- Isolated Systolic Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SER100Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| SER100 | Experimental | SER100 10 mg s.c. twice daily Receives: Drug: SER100; Drug: Placebo |
| Placebo | Placebo comparator | Placebo administered s.c. twice daily Receives: Drug: SER100; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to 4 weeks
Secondary outcomes (1)
Change from baseline in systolic blood pressure
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isolated Systolic HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serodus AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Smerud Medical Research International AS, The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Helga Gudmundsdottir, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987284
- Sponsor's protocol ID
- SMR-2271
- Other IDs
- 2013-001227-40
- Status last verified
- Oct 2016
- First submitted
- 5 Nov 2013
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01987284
- Acronym / sponsor ID
- SMR-2271
- Conditions
- Isolated Systolic Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Serodus ASIndustry (pharma, biotech, devices)
- Collaborators
- Smerud Medical Research International AS, The Research Council of Norway
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SER100 | Experimental | Drug: SER100, Drug: PlaceboSER100 10 mg s.c. twice daily |
| Placebo | Placebo comparator | Drug: SER100, Drug: PlaceboPlacebo administered s.c. twice daily |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SER100 | Drug | Placebo, SER100 |
| Placebo | Drug | Placebo, SER100 |
Primary outcome
Number of participants with adverse events
Time frame: Up to 4 weeks
1 secondary outcome
Change from baseline in systolic blood pressure
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helga Gudmundsdottir, MD principal investigator
Oslo University Hospital
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SER100 in people with Isolated Systolic Hypertension, run by Serodus AS at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Finland, Norway, United Kingdom, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.