Status:
TERMINATED
Vitamin D Deficiency in Patients With Hypertension
Lead Sponsor:
UConn Health
Collaborating Sponsors:
Novartis
Conditions:
Vitamin D Deficiency
Hypertension
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the effects of Vitamin D replacement and the effects of an approved medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who have low levels...
Detailed Description
This study will assess whether aliskiren will lower clinic blood pressure and 24-hour blood pressure in patients with hypertension and vitamin D deficiency. Additionally, this study will further explo...
Eligibility Criteria
Inclusion
- Men or women over 21 years of age with a history of Stage 1 or 2 hypertension (defined as a seated diastolic BP ≥ 90 mmHg and \< 110 mmHg in the untreated state).
- Patients under treatment for hypertension must be willing and able to discontinue any previous antihypertensive medications for the duration of the study.
- 25-hydroxyvitamin D levels \< 30 ng/ml and \> 12 ng/ml.
- Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial, must have a negative serum pregnancy test at screening, and must have a negative urine pregnancy test within 7 days before initiating aliskiren therapy.
Exclusion
- Vitamin D levels \< 12 ng/ml
- Known hypersensitivity or allergy to aliskiren
- Clinic blood pressure \> 180/110 mmHg
- Known forms of secondary hypertension
- Chronic atrial fibrillation
- Uncontrolled or unstable cardiovascular diseases
- Shift or night workers
- Mid-arm circumference \> 42 cm in diameter
- Current or recent (\<1 year) alcohol or drug abuse
- Pregnant or lactating women
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00974922
Start Date
August 1 2009
End Date
December 1 2011
Last Update
March 9 2018
Active Locations (1)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030