Avoiding Cardiovascular Events Through Combination Therapy In Patients Living With Systolic Hypertension

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

These are initial studies to determine the metabolism and pharmacologic actions of drugs in humans (what are called PK/PD studies or pharmacokinetic / pharmacodynamic studies), the side effects associated with increasing doses (a dose response curve or dose response relationship), and to gain early evidence of effectiveness; may include healthy participants and/or patients. These are sometimes called a first in man study.

Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. Sometimes multiple doses will be studied in these trials to select the appropriate dose for further testing in phase III. These are sometimes called a dose finding study.

Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. These are also called pivotal trials.

After the drug has been approved by a regulatory agency, these are post-marketing studies to delineate additional information including the drug’s risks,benefits, and optimal use in a broader group of real world patients.

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

In a clinical study, participants are often divided into groups.

In interventional studies, participants are prospectively assigned to “arms” and receive different interventions. Assignment to an arm is typically random. Multiple arms allow the effects of different interventions to be compared. Participants in a control arm may receive no intervention, placebo, or an intervention with a known effect.

In observational studies, a pre-defined population may be observed over time and is termed, a cohort. A cohort consists of individuals with some common characteristic(s), for example, age, place of residence/employment, or medical condition. A cohort is observed over time to determine if the presence or absence of an exposure is associated with a health outcome or condition. Other observational studies may compare those with a condition (cases) to those without a condition (control) and evaluate differences in exposures, treatments, or behaviors. The cases and controls may be selected from a larger population or a cohort.

Clinical Trials.gov

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Recruitment status indicates the current stage of a trial, whether it is planned, ongoing, or completed. Possible values include:

• Not yet recruiting: participants are not yet being recruited or enrolled
• Recruiting: participants are currently being recruited and enrolled
• Enrolling by invitation: participants are being (or will be) selected from a predetermined population
• Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but enrollment has completed
• Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient’s last visit has occurred)
• Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume
• Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
• Withdrawn: study halted prematurely, prior to enrollment of first participant

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