Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus

Completed · Phase 4 · Has a placebo group

Conditions studied: Hypertension

In brief

The purpose of the study was to 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 II hypertension.

Key facts

Study ID

NCT00927394

Run by

Novartis

People needed

1143

Starts

2009-05-01

Expected to finish

2011-10-01

Last updated by the study team

2012-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigative Site — Newark, Delaware, United States
• Investigative Site — Kansas City, Missouri, United States
• Investigative Site — Camden, New Jersey, United States
• Investigative Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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