NCT01472796

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Jul 2011

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

2 years

First QC Date

November 11, 2011

Last Update Submit

November 11, 2011

Conditions

Hypertension

Keywords

African AmericanVitamin D deficient

Outcome Measures

Primary Outcomes (1)

  • Change in Ambulatory Systolic Blood Pressure

    from baseline (Week 10) to Week 18

Secondary Outcomes (9)

  • Change in ambulatory diastolic blood pressure

    from baseline (Week 10) to Week 18

  • Change in cuff systolic blood pressure

    from baseline (Week 10) to Week 18

  • Change in cuff diastolic blood pressure

    from baseline (week 10) to Week 18

  • Change in Urinary albumin:creatinine ratio

    from baseline (week 10) to Week 18

  • Change in plasma isoprostanes

    from baseline (week 10) to Week 18

  • +4 more secondary outcomes

Study Arms (2)

Tekturna (Aliskirin) with vit. D supplementation

ACTIVE COMPARATOR

Tekturna (Aliskiren) 300mg daily and vitamin D supplementation (50,000 IU)every other week.

Dietary Supplement: Vitamin D (cholecalciferol)

Tekturna (Aliskiren) with placebo

PLACEBO COMPARATOR

Tekturna (Aliskiren) 300mg per day supplemented with placebo (vitamin D)

Drug: Tekturna(Aliskiren) plus placebo

Interventions

Vitamin D (cholecalciferol)DIETARY_SUPPLEMENT

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

Also known as: Tekturna (Aliskirin), cholecalciferol
Tekturna (Aliskirin) with vit. D supplementation
Tekturna(Aliskiren) plus placeboDRUG

Aliskiren 300 mg per day supplemented with placebo

Also known as: Tekturna (Aliskirin)
Tekturna (Aliskiren) with placebo

Eligibility Criteria

Age30 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 30-74
  • Systolic Blood Pressure 140-159 mm Hg and Diastolic Blood Pressure \<100 OR Diastolic Blood Pressure 90-99mm Hg and Systolic Blood Pressure \<160mm Hg
  • Vitamin D deficiency: Serum 25-OH D \>= 10 ng/ml (25 nmol/L) to \< 20 ng/ml (50 nmol/L)
  • Not using any antihypertensive medication(s) for the previous 3 months

You may not qualify if:

  • Cancer(other than skin) known HIV or other medical condition that might limit life expectancy.
  • Pregnant or nursing
  • Know adverse reactions to DRI's
  • Hepatitis or liver enzyme elevations \> 1.5x normal
  • Estimated glomerular filtration rate (EGFR) \<50 ml/min/1.7m2
  • Diabetes Mellitus
  • Serum calcium \> 10.5 mg/dl or history of hypercalcemia
  • History of primary hyperparathyroidism
  • Sarcoidosis or other granulomatous disease
  • Taking \> 500 mg/d of supplemental elemental calcium
  • Taking any drugs that decrease absorption of vitamin D, ex:xenical
  • Taking the drug cyclosporine
  • Taking any antihypertensive medications in the previous 3 months
  • History of kidney stones
  • Planning to move \> 50 miles in the next 9 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University, 4201 St. Antoine

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Cholecalciferolaliskiren

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • John M Flack, M.D., M.P.H.

    Wayne State University, TRaCE Research Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol A Muzyk, CCRP

CONTACT

313-745-2378cmuzyk@med.wayne.edu

Donna Ford

CONTACT

888-235-5467

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Dept. of Internal Medicine, Wayne State University

Study Record Dates

First Submitted

November 11, 2011

First Posted

November 16, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2013

Study Completion

March 1, 2014

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations

US(1)