Hyperuricemia on Hypertension and Metabolic Syndrome
Effect of Hyperuricemia Treatment on Hypertension and Metabolic Syndrome
2 other identifiers
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the influence of hyperuricemia treatment compared with placebo on participants with high risk of hypertension and metabolic syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2010
Shorter than P25 for phase_2
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
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 7, 2010
CompletedFirst Posted
Study publicly available on registry
July 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedJuly 24, 2014
July 1, 2014
7 months
July 7, 2010
July 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of hyperuricemia treatment on systemic blood pressure
participants will be randomized to a 4 week placebo versus alopurinol treatment followed by a wash out period. After crossover them, they will receive the complementary pharmacological intervention for another 4 weeks.
14 weeks
Secondary Outcomes (1)
Effect of hyperuricemia treatment on metabolic syndrome parameters
14 weeks
Study Arms (2)
Allopurinol treatment
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- adults with blood pressure from 120/80 mmHg and less than 140/90 mmHg
- no pharmacological treatment for blood pressure control
You may not qualify if:
- hypertension (more than 140/90mmHg)
- Diabetes Mellitus type 1 or 2
- Chronic kidney disease (MDRD less than 60)
- Hepatic Disease
- Malignancy
- Pregnancy
- patient receiving any medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Insituto Nacional de Cardiología Ignacio Chávez
México, State of Mexico, 14080, Mexico
Related Publications (1)
Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.
PMID: 21849262DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magdalena Madero, MD
Instituto Nacional de Cardiología Ignacio Chávez
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Nephrology Division
Study Record Dates
First Submitted
July 7, 2010
First Posted
July 8, 2010
Study Start
July 1, 2010
Primary Completion
February 1, 2011
Study Completion
August 1, 2011
Last Updated
July 24, 2014
Record last verified: 2014-07