Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT01432106
Eligibility Criteria:
Inclusion Criteria:
1. African American men or women 18 - 80 years of age.
2. Appropriate therapy for high blood pressure consisting of no more than 2 antihypertensives.
3. 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)
4. Recent copy of EKG.
5. 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 Criteria:
1. Uncontrolled hypertension.
2. Organ transplant.
3. Hypersensitivity to any study medications
4. Systolic pressure 170 or higher or Diastolic pressure 110 or higher.
5. Cardiovascular events within last 6 months Stroke, Heart Attack, Stent, or Hospitalization for severe Heart Failure.
6. Serum potassium greater than 5.0
7. Heart block without a pacemaker, continuing arrhythmia or valvular heart disease.
8. Blocked renal artery.
9. 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.
10. Any condition that may alter medication absorption.
11. Any condition that may place patient at higher risk from participating in study or will jeopardize the evaluation of efficacy or safety.
12. Use of any investigational study medications within 30 days of enrollment
13. Persons unwilling or unable to take regular medications or comply with study protocol.
14. 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01432106
Study Brief:
Protocol Section:
NCT01432106