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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00927394
Eligibility Criteria:
Inclusion Criteria:
* Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
* Men or women 18 years and older.
* Patients with Type 2 diabetes mellitus with an HbA1c ≤ 9 % at visit 1 and on a stable anti-diabetic regimen not including insulin or stable diet and exercise for at least 4 weeks prior to visit 1.
Cohort 1:
* Patients with Stage 2 systolic hypertension, defined as having a MSSBP ≥160 mmHg and \<200 mmHg at Visit 5 (randomization).
* Patients who have been newly diagnosed with hypertension or who have not received antihypertensive medication for at least 4 weeks (28 days) prior to Visit 1 must have MSSBP ≥ 160 mmHg and \< 200 mmHg at Visit 1, otherwise, they will be considered screen failures.
* Patients receiving antihypertensive medication must have a MSSBP of ≥150 mmHg and \<200 mmHg at Study Visit 1, otherwise they will be considered screen failures.
Cohort 2:
* Patients must also have had a mean 8-hour daytime ambulatory systolic blood pressure (ASBP) ≥140 mmHg AND mean 8-hour daytime ambulatory diastolic blood pressure (ADBP) ≥90 mmHg at Visit 5 (randomization).
* Hypertensive patients with MSSBP ≥150 mmHg and but \<200 mmHg AND MSDBP ≥95 but \<120 mmHg at Visit 5 (randomization).
* Patients who had been newly diagnosed with hypertension or who had not received antihypertensive medication for at least 4 weeks (28 days) prior to Visit 1 must have had MSSBP ≥150 mmHg but \<200 mmHg and MSDBP ≥95 but \<120 mmHg at Visit 1, otherwise, they were considered screen failures.
Exclusion Criteria:
* Office blood pressure measured by cuff (MSSBP ≥200 mmHg or MSDBP ≥120 mmHg).
* History or evidence of secondary hypertension of any etiology.
* Refractory hypertension, defined as having uncontrolled BP (≥140/90 mmHg) while receiving 3 antihypertensive medications at the maximum approved dose of each drug, one of which must be a diuretic.
* Patients treated with more than 3 antihypertensive medications (each component of a combination drug counts individually).
* Type 2 diabetes mellitus currently requiring insulin treatment.
* modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2
* Serum sodium less than lower limit of normal, serum potassium \< 3.5 mEq/L or ≥ 5.3 mEq/L at Visit 1.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
Cohort 1:
\- Patients with known diabetic retinopathy (eg, having a history of laser therapy for diabetic retinopathy) or diabetic neuropathy (eg, receiving medication for diabetic neuropathy).
Cohort 2:
\- Patients with known diabetic retinopathy or diabetic neuropathy and/or having a history of treatment for either.
Other protocol-defined inclusion/exclusion criteria applied.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00927394
Study Brief:
Protocol Section:
NCT00927394