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

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”

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.

Intervention(s) in this Clinical Trial

• 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.
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Aliskiren
  • Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg
• Active Comparator: HCTZ
  • Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg

Primary 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
    Safety Issue?: Yes

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 >5.2 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%
• Hypertension (at Screening): any patient with msSBP ≥ 180 mmHg or msDBP ≥ 110 mmHg
• 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 that is likely to reduce the subject's life span to less than 2 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: William Beaumont Hospitals Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00994253

Study ID Number: 2009-083

ClinicalTrials.gov Identifier: NCT00994253

Health Authority: United States: Institutional Review Board