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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT00952627
Eligibility Criteria:
Inclusion Criteria:
* The subjects will consist of ambulatory males and females, 50-75 years of age, of any race, diagnosed with hypertension (diagnosis made over 6 months), and echocardiographic evidence of grade I or II diastolic dysfunction.
* There is no need for standardization of hypertension treatment, as we select only patients who have diastolic dysfunction during treatment.
Exclusion Criteria:
* Unstable angina or myocardial infarction in the past 3 months.
* Biochemical evidence of renal or hepatic failure.
* Severe anemia: defined as hemoglobin level less than 7 g/dL.
* Current cancer or other major illness not associated with the heart.
* Bleeding disorders.
* Taking anticoagulants including low dose aspirin.
* Diabetes.
* Known allergy to Pycnogenol.
* Being pregnant or breastfeeding.
* Systolic blood pressure over 180 mmHg or less than 100 mmHg, and Diastolic blood pressure over 110 mmHg or less than 50 mmHg.
* Current smoking.
* Having breast implants.
* Taking any of the following: birth control products, Diethylstilbestrol, Ephedra, ephedrine, or pseudoephedrine (except where used in prescription products), hormone replacement products, Isotretinoin, any product containing mercury, Phentermine in combination with fenfluramine (including but not limited to Pondimin) or dexfenfluramine (Redux).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT00952627
Study Brief:
Protocol Section:
NCT00952627