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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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Pivotal 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.

Eligible Conditions
  • High Blood Pressure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
314 Previous Clinical Trials
109,986 Total Patients Enrolled
NovartisIndustry Sponsor
1,636 Previous Clinical Trials
2,773,501 Total Patients Enrolled
John M Flack, M.D., M.P.H.Principal InvestigatorWayne State University, TRaCE Research Group
~6 spots leftby Nov 2025
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