Status:
WITHDRAWN
The Study of Novel Dual Renin Angiotensin Aldosterone System (RAAS) Blockade; Valsartan/Aliskiren in African American Patients With Hypertension and the Metabolic Syndrome
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Hypertension
Metabolic Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
Study purpose: African Americans with hypertension and markers of metabolic syndrome (small elevations in blood glucose, triglycerides and or weight) are at a high risk of cardiovascular (heart and bl...
Detailed Description
The specific hypothesis of this proposal is that the combination of Valsartan/Aliskiren will provide incremental reduction in blood pressure when compared to traditional blockade of Renin Angiotensin ...
Eligibility Criteria
Inclusion
- African American men or women 18 - 80 years of age.
- Appropriate therapy for high blood pressure consisting of no more than 2 antihypertensives.
- Patients with at least one marker of Metabolic Syndrome as evidenced by:
- HDL cholesterol \< 35mg/dl (men); \< 45 mg/dl (women)
- Triglycerides \> 200mg/dl
- Fasting Glucose \>100mg/dl
- Waist Circumference: Men \>40 inches (102cm); Women \> 35 (88cm)
- Recent copy of EKG.
- Women able to become pregnant must use reliable contraception (e.g. hormonal contraception and double-barrier methods) throughout this study and for one week after the end of this study. Post-menopausal or surgically sterile women.
Exclusion
- Uncontrolled hypertension.
- Organ transplant.
- Hypersensitivity to any study medications
- Systolic pressure 170 or higher or Diastolic pressure 110 or higher.
- Cardiovascular events within last 6 months Stroke, Heart Attack, Stent, or Hospitalization for severe Heart Failure.
- Serum potassium greater than 5.0
- Heart block without a pacemaker, continuing arrhythmia or valvular heart disease.
- Blocked renal artery.
- Patients with severe renal impairment (creatinine 1.7 mg/dl for women and 2.0 mg/dl for men and or estimated GFR \<30 mL/min) a history of dialysis, nephritic syndrome, or reno-vascular hypertension.
- Any condition that may alter medication absorption.
- Any condition that may place patient at higher risk from participating in study or will jeopardize the evaluation of efficacy or safety.
- Use of any investigational study medications within 30 days of enrollment
- Persons unwilling or unable to take regular medications or comply with study protocol.
- Pregnant or nursing (lactating) women, or women of childbearing potential (defined as all women physiologically capable of becoming pregnant) who do not use reliable methods of contraception: surgical sterilization, bilateral tubal ligation, hormonal contraception, implantable and oral) and double barrier methods if accepted by local regulatory authority and ethics committee. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01432106
Start Date
February 1 2011
End Date
December 1 2012
Last Update
November 18 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48106