NCT01987284

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

November 5, 2013

Last Update Submit

October 19, 2016

Conditions

Isolated Systolic Hypertension

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    Up to 4 weeks

Secondary Outcomes (1)

  • Change from baseline in systolic blood pressure

    Up to 4 weeks

Study Arms (2)

SER100

EXPERIMENTAL

SER100 10 mg s.c. twice daily

Drug: SER100Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo administered s.c. twice daily

Drug: SER100Drug: Placebo

Interventions

SER100DRUG
PlaceboSER100
PlaceboDRUG
PlaceboSER100

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

FinnMedi Oy/Valkeakoski District Hospital

Tampere, Finland

Location

CRST/Turku University Hospital

Turku, Finland

Location

Semmelweiss University Hospital

Budapest, Hungary

Location

Medi3 Innlandet

Hamar, 2317, Norway

Location

Ulleval University Hospital

Oslo, 0450, Norway

Location

Northwick Park Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Brighton and Sussex University Hospital

Brighton, United Kingdom

Location

MeSH Terms

Conditions

Isolated Systolic Hypertension

Interventions

ZP120

Condition Hierarchy (Ancestors)

Essential HypertensionHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Helga Gudmundsdottir, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 19, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

October 20, 2016

Record last verified: 2016-10

Locations

NO(2)FI(2)GB(2)HU(1)