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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT02047656
Eligibility Criteria:
Inclusion Criteria:
Part 1
\- Healthy men and women of non-childbearing potential, 18 to 80 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
Part 2
* Hypertensive men and women of non-childbearing potential, 18 to 80 years of age inclusive.
* Patients with mild-to-moderate uncomplicated essential hypertension
Exclusion Criteria:
Part 1
* History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes.
* A history of clinically significant ECG abnormalities.
* Known history or current clinically significant arrhythmias.
* History of hypertension, adrenal or endocrine disease.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
* Smokers (use of tobacco products in the previous 3 months).
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* A positive Hepatitis B surface antigen or Hepatitis C test result.
Part 2
* Pregnant or nursing (lactating) women.
* Women of child-bearing potential.
* Known history or evidence of a secondary form of hypertension
* Type 1 or type 2 diabetes mellitus.
* History of heart diseases
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
Other protocol defined inclusion/exclusion criteria may apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02047656
Study Brief:
Protocol Section:
NCT02047656