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:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT00350168
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older.
* Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg.
Exclusion Criteria:
* History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics
* Inability to stop all prior blood pressure medications safely
* Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg
* Controlled blood pressure (systolic BP \< 140 mmHg) taking more than 3 antihypertensive medications at screening
* Systolic BP ≥ 140 mmHg and \< 180 mmHg taking more than two antihypertensive medications at screening
* Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening
* History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina
* Type 1 diabetes
* Poorly controlled Type 2 diabetes
* History of heart failure
* Arrhythmia
* Significant valvular heart disease
* Active gout
* History of autoimmune diseases
* History of multiple drug allergies
* Liver disease
* Pancreatic injury within 1 year of screening
* Evidence of kidney impairment or history of dialysis
* Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. This could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction.
* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, would be excluded UNLESS they are post-menopausal, surgically sterile OR are using acceptable methods of contraception. The use of hormonal contraceptives is not allowed
* Pregnant or nursing (lactating) women
* History of malignancy of any organ system within the past five years
* Any severe, life-threatening disease within the past five years
* History of drug or alcohol abuse within the last 2 years.
Other protocol-defined inclusion/exclusion criteria may apply
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00350168
Study Brief:
Protocol Section:
NCT00350168