NCT00818779

Brief Summary

The investigators aim to assess if a new blood pressure medication, aliskiren, reduces various biomarkers of heart disease found in the blood in patients with a history of both heart disease and type 2 diabetes. The primary hypothesis is that aliskiren will reduce these biomarkers compared to a calcium channel blocker.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jan 2008

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 19, 2012

Completed
Last Updated

December 5, 2017

Status Verified

October 1, 2017

Enrollment Period

3.6 years

First QC Date

January 6, 2009

Results QC Date

June 18, 2012

Last Update Submit

October 31, 2017

Conditions

Coronary Artery DiseaseType 2 Diabetes Mellitus

Keywords

diabetesheart diseaseatherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Plasminogen Activator Inhibitor 1

    Plasminogen Activator Inhibitor 1 is a biomarker found in serum that indirectly assesses blood clotting activity. Lower PAI-1 levels are thought to be better than higher levels. The primary outcome is mean change from baseline and can include negative numbers as a result.

    6 weeks (change from baseline)

Secondary Outcomes (4)

  • Serum Level of Vascular Cell Adhesion Molecule

    6 week (change from baseline)

  • Serum Level of Intracellular Cell Adhesion Molecule

    6 week (change from baseline)

  • Serum Level of C-reactive Protein

    6 week (change from baseline)

  • Serum Level of Nitric Oxide

    6 week (change from baseline)

Study Arms (2)

Aliskiren

EXPERIMENTAL

Aliskiren 150-300 mg once daily

Drug: Aliskiren

Amlodipine

ACTIVE COMPARATOR

5-10 mg amlodipine once daily

Drug: Amlodipine

Interventions

AliskirenDRUG

150 - 300 mg once daily for 6 weeks

Also known as: Tekturna
Aliskiren
AmlodipineDRUG

5-10 mg once daily for 6 weeks

Also known as: Norvasc
Amlodipine

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 diabetes
  • Diagnosis of coronary artery disease
  • Currently receiving therapy with an ACE-Inhibitor or Angiotensin Receptor Blocker
  • Currently receiving antiplatelet therapy and statin therapy
  • Baseline blood pressure \> 100/75 mm Hg
  • BMI 25-35 kg/m2

You may not qualify if:

  • Concurrent calcium channel blocker therapy
  • Documented peripheral edema
  • Hyperkalemia
  • Serum creatinine \> 2.0
  • Diagnosed with proteinuria
  • Diagnosed with liver dysfunction or serious rheumatological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes Mellitus, Type 2Diabetes MellitusHeart DiseasesAtherosclerosis

Interventions

aliskirenAmlodipine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Small sample size led to large standard deviation in biomarkers assessed and limited power to detect a diffference

Results Point of Contact

Title
Gary Meyerrose
Organization
Texas Tech University Health Sciences Center School of Medicine
gary.meyerrose@ttuhsc.edu
806-743-3150

Study Officials

  • Gary E Meyerrrose, MD

    Texas Tech Health Sciences Center Department of Internal Medicine

    PRINCIPAL INVESTIGATOR

  • Brian K Irons, PharmD

    Texas Tech University Health Sciences Center School of Pharmacy

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 8, 2009

Study Start

January 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

December 5, 2017

Results First Posted

November 19, 2012

Record last verified: 2017-10

Locations

US(1)