Featured Clinical Trial:
Hypertension (product/compound: Aliskiren/Valsartan)
| High Blood Pressure & Type 2 Diabetes CAUTION! Diabetes increases your risk for high blood pressure. Physicians are studying the investigational use of two approved high blood pressure medications in people with type 2 diabetes. You may participate if you have been diagnosed with type 2 diabetes and have, or think you may have, high blood pressure. To qualify you must be on a stable diabetes treatment, but not taking insulin. Qualified participants receive study-related care, including physical exams, lab services and high blood pressure medication at no cost. To learn more, call today: 888-757-8881 x 51 |
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ClinicAid Locations: Southern California – Norco
Status: Enrollment closed.
Condition: Hypertension
Product Name/Compound: Aliskiren/Valsartan
Full Study Title: An 8 Week Randomized, Double-Blind, Parallel Group, Multi-Center, Active Controlled Study to Evaluate the Antihypertensive Efficacy and Safety of Aliskiren Administered in Combination With Valsartan Versus Valsartan Alone in Patients With Stage 2 Systolic Hypertension and Type 2 Diabetes Mellitus (ViVID)
Study Summary: Evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage I hypertension.
Eligible Participants:
Inclusion (Eligible):
- Men or women 18 years and older.
- 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.
- 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.
Exclusion (Not Eligible):
- 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.
- MDRD estimated GFR (eGFR) <60 mL/min/1.73m 2
- 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.
Study Phase: Phase IV (What are Phases?)
To receive information and updates for this trial:
Please contact us and mention the Trial ID below.
Trial ID (ClinicalTrials.gov): NCT00927394
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