Trial record 1 of 2 for:    Antihypertensives and Vascular, Endothelial and Cognitive Function Trial
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The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial (AVEC)

This study has been completed.
Sponsor:
Collaborators:
Hebrew SeniorLife
Information provided by (Responsible Party):
Ihab Hajjar, University of Southern California
ClinicalTrials.gov Identifier:
NCT00605072
First received: January 11, 2008
Last updated: January 14, 2013
Last verified: January 2013
Results First Received: December 4, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cognitive Impairment
Hypertension
Aging
Interventions: Drug: candesartan
Drug: lisinopril
Drug: hydrochlorothiazide
Drug: nifedipine, long acting
Drug: metoprolol, long-acting

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lisinopril

Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months

nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments

metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg

Candesartan

Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months

nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments

metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg

HCTZ

hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months

nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments

metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg


Participant Flow:   Overall Study
    Lisinopril     Candesartan     HCTZ  
STARTED     18     20     15  
COMPLETED     11     9     11  
NOT COMPLETED     7     11     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ACEI (Lisinopril)

Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months

nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments

metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg

ARB (Candesartan)

Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months

nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments

metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg

HCTZ

hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months

nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments

metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg

Total Total of all reporting groups

Baseline Measures
    ACEI (Lisinopril)     ARB (Candesartan)     HCTZ     Total  
Number of Participants  
[units: participants]
  18     20     15     53  
Age  
[units: years]
Mean ± Standard Deviation
  71  ± 7     71  ± 9     71  ± 7     71  ± 7  
Gender  
[units: participants]
       
Female     11     11     9     31  
Male     7     9     6     22  
Region of Enrollment  
[units: participants]
       
United States     18     20     15     53  



  Outcome Measures
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1.  Primary:   Cognitive Assessment: Trail Making Test Part B   [ Time Frame: Baseline-12 months ]

2.  Primary:   Cognitive Assessment: Hopkins Verbal Learning- Immediate Recall   [ Time Frame: Baseline-12 months ]

3.  Primary:   Cognitive Assessment: Forward Digit Span Test   [ Time Frame: Baseline-12 months ]

4.  Secondary:   Blood Pressure Outcome: Systolic BP   [ Time Frame: Baseline-12 months ]

5.  Secondary:   Blood Flow Velocity, Sitting   [ Time Frame: Baseline-12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The main limitation is the small sample size. The validity of TCD measurements as an index of cerebral blood flow is based on the assumption that cerebral vessel diameters are constant but we didn't have brain imaging to validate this assumption.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ihab Hajjar
Organization: University of Southern California
phone: 323-226-6720
e-mail: ihajjar@usc.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Ihab Hajjar, University of Southern California
ClinicalTrials.gov Identifier: NCT00605072     History of Changes
Other Study ID Numbers: IA0127, K23AG030057
Study First Received: January 11, 2008
Results First Received: December 4, 2012
Last Updated: January 14, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board