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

Condition(s) targeted: Hypertension

Intervention: Aliskiren/Valsartan (Drug); Valsartan (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

Overall contact:
Novartis, Phone: 862-778-8300

The purpose of the study is 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.

Official 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Primary outcome: Change from baseline in MSSBP

Secondary outcome:

Change from baseline in MSDBP

Percentage of patients achieving BP control (defined as MSSBP < 130 mmHg and MSDBP <80)

Percentage of responders (defined as patients with MSSBP <130 mmHg or a reduction from baseline in MSSBP of >20 mmHg)

Change in MSSBP in patients with baseline MSSBP ≥180 mmHg and <200 mmHg and Type 2 diabetes mellitus

Safety and tolerability of the combination of aliskiren and valsartan versus valsartan monotherapy

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 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 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.

- MDRD estimated GFR (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.

- Other protocol-defined inclusion/exclusion criteria may apply.

Novartis, Phone: 862-778-8300

Investigative Site, Newark, Delaware USA, United States; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Kansas, Missouri, United States; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Camden, New Jersey, United States; Recruiting
Novartis, Phone: 862-778-8300

Investigative Site, Philadelphia, Pennsylvania, United States; Recruiting
Novartis, Phone: 862-778-8300

Starting date: May 2009
Last updated: June 24, 2009