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NCT01650402 · ClinicalTrials.gov registry record · NA
Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
A NA study of Cerebrovascular Disease and Hypertension, Systolic, sponsored by UConn Health.
- Completed
- Registry status
- NA
- Development phase
- 199
- Enrollment target
- 1
- Study location
NCT01650402: Completed NA study of Cerebrovascular Disease and Hypertension, Systolic, sponsored by UConn Health.
NCT01650402 is a NA study of Cerebrovascular Disease and Hypertension, Systolic that has completed, run by UConn Health. The registered enrollment target is 199 participants, below the 1,208-participant average among 7 other Cerebrovascular Disease trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01650402, a NA study of Cerebrovascular Disease and Hypertension, Systolic, has completed, sponsored by UConn Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 199 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \<130 mmHg (intensive control) versus \<145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also known as white-matter hyperintensity or WMH) in patients with normal or mildly impaired mobility and cognition in subjects with detectable cerebrovascular disease (\>0.5% WMH fraction of intracranial contents). The study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of \< 130 mmHg or standard to achieve a goal 24-hour systolic blood pressure of \< 145 mmHg) for a total of 36 months.
Primary Outcome
Change in gait speed (walking 8 meters) in seconds mediated by the accrual of white-matter hyperintensity lesions (WMH/intracranial cavity volume) using MRI and including degeneration of axonal and myelin components of white matter using MRI technology known as diffusion tensor imaging (DTI).
Conditions Studied
Interventions
- OTHER Anti-hypertensive therapy to SBP 130 mm Hg
- OTHER Anti-hypertensive therapy to SBP 145 mm Hg
Study Locations (1)
Connecticut
- University of Connecticut Health Center - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2011-12 |
| Est. Completion | 2018-10 |
| Phase | NA |
What the finished NCT01650402 record still lists
NCT01650402 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 1,208-participant average among 7 other Cerebrovascular Disease trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Cerebrovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Anti-hypertensive therapy to SBP 130 mm Hg is the first listed.
NCT01650402 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT01650402 about?
NCT01650402 is a clinical study titled "Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People". This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \<130 mmHg (intensive control) versus \<145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also k...
What is the current status of trial NCT01650402?
This trial is currently completed. It is a NA study. The enrollment target is 199 participants. The study started on 2011-12. Estimated completion is 2018-10.
What conditions does trial NCT01650402 study?
This clinical trial studies the following conditions: Cerebrovascular Disease, Hypertension, Systolic.
What interventions are being tested in trial NCT01650402?
The interventions under investigation include: Anti-hypertensive therapy to SBP 130 mm Hg (OTHER), Anti-hypertensive therapy to SBP 145 mm Hg (OTHER).
Who is sponsoring clinical trial NCT01650402?
This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01650402 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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