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:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT01307033
Eligibility Criteria:
Inclusion criteria:
* Participant has a diagnosis of essential hypertension.
* Participant is being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
* Participant has a mean trough SiDBP of \>=90mmHg and \< 110mmHg.
* Participant has a mean trough SiSBP of \>=140mmHg and \< 200mmHg.
* Participant has no clinically significant abnormality at screening visit.
Exclusion criteria:
* Participant is currently taking \> 2 antihypertensive medications.
* Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-lotan or Preminent and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines).
* Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence.
* Participant is pregnant or breastfeeding, or expecting to conceive or the pregnancy test is positive at screening visit.
* Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT01307033
Study Brief:
Protocol Section:
NCT01307033