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Trial to Evaluate the Effect of Tektura (Aliskiren), Angiotensin Inhibitors, Diuretics, and Calcium Channel Blockers on Coronary Flow Reserve in Patients With Type II Diabetes and Hypertension
This study is currently recruiting participants.
Verified by William Beaumont Hospitals, October 2009
First Received: October 12, 2009   Last Updated: October 13, 2009   History of Changes
Sponsor: William Beaumont Hospitals
Collaborator: Novartis Pharmaceuticals
Information provided by: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00994253
  Purpose

The purpose of this study is to assess the effect of Tekturna (aliskiren), in combination with an ACE and calcium channel blocker in hypertensive patients diagnosed with Type II diabetes.


Condition Intervention Phase
Hypertension
Diabetes Type 2
Drug: Prescribe Aliskiren
Drug: HCTZ
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
Official Title: A Prospective, Randomized, Open-label Clinical Trial to Evaluate the Effect of Tektura (Aliskiren), Angiotensin Inhibitors, Diuretics, and Calcium Channel Blockers on Coronary Flow Reserve in Patients With Type II Diabetes and Hypertension

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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 CRF in hypertensive patients diagnosed with Type II diabetes. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Aliskiren: Experimental

Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include:

Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg

Drug: Prescribe 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 lisinopril40mg and amlodipine 5mg po daily.
HCTZ: Active Comparator

Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include:

Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg

Drug: HCTZ
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. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-85
  • Diagnosed with Type II Diabetes and Hypertension
  • Taking either ACE or ARB in addition to any other antihypertensive medication excluding aliskiren
  • Blood Pressure >130/80

Exclusion Criteria:

  • Serum Potassium >5.0 mmol/L
  • History of any cardiovascular event (stroke, TIA, unstable angina, CABG, percutaneous coronary intervention, hospitalization due to HF) during the 3 months prior to Visit 1.
  • History of MI
  • Documented ejection fraction of <50%
  • Congestive Heart Failure NYHA class III and IV
  • Concomitant treatment with two (2) or more renin-angiotensin-aldosterone system blocking agents, e.g. ACE inhibitor, ARB or aldosterone-antagonist.
  • Unstable serum creatinine
  • Second (II) or third (III) degree heart block without a pacemaker
  • Concurrent potentially life threatening arrythmia or other uncontrolled arrythmia
  • Clinically significant valvular heart disease
  • Known renal artery stenosis
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drugs including, but not limited to, any of the following:

    • History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection (patients with previous bariatric surgery>6 months prior to Visit 1 are allowed to participate).
    • Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase.
    • Evidence of hepatic disease as determined by any one of the following: SGPT value exceeding 3x Upper Limit of Normal (ULN) at Visit 1, a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt.
  • History of malignancy other than basal cell skin cancer within the past five years
  • Any concurrent life threatening condition with a life expectancy less than 2 years
  • History or evidence of drug or alcohol abuse with the last 12 months
  • Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
  • History of hypersensitively to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs
  • History of noncompliance to medical regimens or unwillingness to comply with the study protocol
  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  • Any condition that in the opinion of the investigator would jeopardized the evaluation of efficacy or safety
  • Persons directly involved in the execution of this protocol
  • Pregnant or nursing (lactating) women
  • Women of Child Bearing Potential unless post menopausal for at least one year, surgically sterile or using effective methods of contraception as defined by local Health Authorities.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994253

Contacts
Contact: Scott Billecke, PhD Scott.Billecke@beaumont.edu

Locations
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Deborah Collins-Bohler     248-898-2697     Deborah.Collins-Bohler@beaumont.edu    
Principal Investigator: Pamela Marcovitz, MD            
Sponsors and Collaborators
William Beaumont Hospitals
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: William Beaumont Hospital ( Pamela Marcovitz, MD )
Study ID Numbers: 2009-083
Study First Received: October 12, 2009
Last Updated: October 13, 2009
ClinicalTrials.gov Identifier: NCT00994253     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration

Additional relevant MeSH terms:
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Diuretics
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Calcium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Glucose Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010