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Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension

NCT01472796 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2011-11-16

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D (cholecalciferol)

Tekturna (Aliskirin) 300 mg per day supplemented with 50,000 IU Vitamin D every other week x 8 weeks

DRUG

Tekturna(Aliskiren) plus placebo

Aliskiren 300 mg per day supplemented with placebo

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Wayne State University

    lead OTHER

Principal Investigators

  • John M Flack, M.D., M.P.H. · Wayne State University, TRaCE Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-07-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01472796 on ClinicalTrials.gov