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Renin Inhibitor

Tekturna (Aliskirin) with vit. D supplementation for High Blood Pressure (VDATH Trial)

Phase 4
Waitlist Available
Led By John M Flack, M.D., M.P.H.
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 10) to week 18
Awards & highlights

VDATH Trial Summary

In this research study, the goal is to find out if a currently FDA-approved medication called Tekturna(Aliskiren) along with the addition of Vitamin D will lower blood pressure and improve heart function in the African American population. High blood pressure occurs earlier in life in African Americans, is more severe, and is associated with greater organ damage in relation to uncontrolled hypertension. Having low levels of Vitamin D is also very common in the African American population. Research has shown that there may be a link between low Vitamin D levels and the ability of high blood pressure medications to be fully effective.

VDATH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 10) to week 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 10) to week 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Ambulatory Systolic Blood Pressure
Secondary outcome measures
Change in Urinary albumin:creatinine ratio
Change in ambulatory diastolic blood pressure
Change in cuff diastolic blood pressure
+6 more

VDATH Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Tekturna (Aliskirin) with vit. D supplementationActive Control1 Intervention
Tekturna (Aliskiren) 300mg daily and vitamin D supplementation (50,000 IU)every other week.
Group II: Tekturna (Aliskiren) with placeboPlacebo Group1 Intervention
Tekturna (Aliskiren) 300mg per day supplemented with placebo (vitamin D)

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,381 Total Patients Enrolled
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,720,943 Total Patients Enrolled
John M Flack, M.D., M.P.H.Principal InvestigatorWayne State University, TRaCE Research Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension
John M. Flack 2011. "Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01472796.
All > High Blood Pressure > Vitamin D
~7 spots leftby Apr 2025
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