Danish Hypertension Prevention Project - DHYPP
1 other identifier
interventional
100
1 country
1
Brief Summary
The present study examine healthy, normotensive subjects 18 to 36 years of age whose both parents have essential hypertension. The subjects receive treatment with either the AT1-antagonist candesartan cilexetil, 16 mg daily or placebo for one year. Then, treatment is withdrawn and the subjects is followed for 10 years to determine if the treatment has been able to either prevent or delay the development of hypertension. The primary objective is to determine whether pharmacological treatment with an angiotensin receptor blocker is able to restrain or delay the progression to hypertension. Secondary objectives are to investigate whether any long-term effect on blood pressure is related to the effect of treatment on renal haemodynamic function, or on the left ventricle mass.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hypertension
Started Nov 2000
Longer than P75 for phase_3 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedNovember 26, 2014
November 1, 2014
3.2 years
September 6, 2005
November 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The primary outcome is to determine whether pharmacological treatment with an angiotensin receptor blocker is able to restrain or delay the progression to hypertension.
10 years
Secondary outcomes are to investigate whether any long-term effect on blood pressure is related to the effect of treatment on renal haemodynamic function, or on the left ventricle mass.
1 year
Study Arms (2)
active (candesartan)
PLACEBO COMPARATOR12 mo treatment with candesartan
placebo
PLACEBO COMPARATOR12 mo placebo treatment
Interventions
Eligibility Criteria
You may qualify if:
- Both parents have essential hypertension
- Age 18 - 36 years
- Caucasians
- Female participants using orale anticonceptives ot intrauterine devices
You may not qualify if:
- Clinical or biochemically signs of disease in kidney, liver, or endocrine organs
- Pregnancy or pregnancy wish
- Daily medication, except for orale anticoncetives -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karin Skovlead
- University of Aarhuscollaborator
- AstraZenecacollaborator
Study Sites (1)
Karin Skov
Aarhus, 8000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
michael mulvany, prof
Dept. of Pharmacology, Aarhus University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- consultant, ph.d.
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
November 1, 2000
Primary Completion
January 1, 2004
Study Completion
December 1, 2014
Last Updated
November 26, 2014
Record last verified: 2014-11