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Evaluating the Effect of Aliskiren Versus HCTZ on Coronary Flow Reserve in Hypertensive Type II Diabetics

This study has been terminated.
(Safety concerns regarding the concomitant use of aliskiren with an ACEi or ARB.)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Pam Marcovitz, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00994253
First received: October 12, 2009
Last updated: December 7, 2016
Last verified: December 2016
Results First Received: December 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hypertension
Diabetes Type 2
Interventions: Drug: Aliskiren
Drug: Hydrochlorothiazide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The plan was to recruit patient in Women's Heart Center clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

The study was never begun ( because of an unexpected possible negative effect of the drug that was announced after our IRB approval but before the initiation of the study)

No data collected,no patients enrolled, no patients contacted.


Reporting Groups
  Description
Aliskiren

Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.

Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg

Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily.

Hydrochlorothiazide

HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.

Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg

Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily


Participant Flow:   Overall Study
    Aliskiren   Hydrochlorothiazide
STARTED   0   0 
COMPLETED [1]   0   0 
NOT COMPLETED   0   0 
[1] No data collected,no patients enrolled, no patients contacted.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aliskiren

Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.

Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg

Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily.

Hydrochlorothiazide

HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.

Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg

Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily

Total Total of all reporting groups

Baseline Measures
   Aliskiren   Hydrochlorothiazide   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   0   0 


  Outcome Measures

1.  Primary:   The Primary Objective is to Assess the Effect of a Multimodal Drug Therapy Regimen Including the Renin Inhibitor Tekturna (Aliskiren), an ACE Inhibitor, and a Calcium Channel Blocker on Coronary Flow Reserve (CFR) in Hypertensive Type II Diabetics.   [ Time Frame: 6 months ]

2.  Secondary:   Secondary Measures Include Evaluation of Serum and Urine Biomarkers Related to Endothelial Function, the Renin-angiotensin System, Oxidative Stress, and Inflammation.   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Pamela Marcovitz
Organization: William Beaumont Hospital
phone: 248-898-8794
e-mail: pamela.marcovitz@beaumont.edu



Responsible Party: Pam Marcovitz, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00994253     History of Changes
Other Study ID Numbers: 2009-083
Study First Received: October 12, 2009
Results First Received: December 7, 2016
Last Updated: December 7, 2016