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SER100 in Isolated Systolic Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987284
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : October 20, 2016
Sponsor:
Collaborators:
Smerud Medical Research International AS
The Research Council of Norway
Information provided by (Responsible Party):
Serodus ASA

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.


Condition or disease Intervention/treatment Phase
Isolated Systolic Hypertension Drug: SER100 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : October 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2014


Arm Intervention/treatment
Experimental: SER100
SER100 10 mg s.c. twice daily
Drug: SER100
Drug: Placebo
Placebo Comparator: Placebo
Placebo administered s.c. twice daily
Drug: SER100
Drug: Placebo



Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Up to 4 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in systolic blood pressure [ Time Frame: Up to 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987284


Locations
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Finland
FinnMedi Oy/Valkeakoski District Hospital
Tampere, Finland
CRST/Turku University Hospital
Turku, Finland
Hungary
Semmelweiss University Hospital
Budapest, Hungary
Norway
Medi3 Innlandet
Hamar, Norway, 2317
Ulleval University Hospital
Oslo, Norway, 0450
United Kingdom
Northwick Park Hospital
Harrow, Middlesex, United Kingdom, HA1 3UJ
Brighton and Sussex University Hospital
Brighton, United Kingdom
Sponsors and Collaborators
Serodus ASA
Smerud Medical Research International AS
The Research Council of Norway
Investigators
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Principal Investigator: Helga Gudmundsdottir, MD Oslo University Hospital
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Responsible Party: Serodus ASA
ClinicalTrials.gov Identifier: NCT01987284    
Other Study ID Numbers: SMR-2271
2013-001227-40 ( EudraCT Number )
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases