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.
When protocol Amendment 2 was released, there were patients who had already been randomized into the study. These patients were included in the trial prior to making changes to the eligibility criteria. Thus, the study contains 2 distinct cohorts. Cohort 1 contains those patients who had already been randomized, and had been deemed eligible based on the original inclusion/exclusion criteria, prior to Amendment 2. No new patients were randomized to Cohort 1. Cohort 2 contains patients who were randomized, having been found eligible based on the revised inclusion/exclusion criteria, after Amendment 2. Differences in the inclusion and exclusion criteria are indicated below.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,143
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
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8
The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.
Time frame: baseline, week 8
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.
Time frame: Baseline, week 8
Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8
The 24-hour ambulatory diastolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly diastolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MADBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24.
Time frame: baseline, week 8
Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8
The 24-hour ambulatory pulse pressure was evaluated at baseline (Week 0) and post-baseline visits.
Time frame: baseline, week 8
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Placebo for Valsartan 160 mg capsules
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit.
Time frame: Baseline, week 8
Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8
At each visit, the pulse rate was measured for 30 seconds just prior to the first sitting blood pressure measurement.
Time frame: baseline, week 8
Percentage of Patients Achieving Blood Pressure Control
Blood pressure control was defined as MSSBP/MSDBP \<140/90 mmHg. Percentage of patients achieving of blood pressure control at the corresponding visit was reported
Time frame: 8 weeks
Percentage of Responders
Responders were defined as patients with MSSBP \<130 mmHg or a reduction from baseline in MSSBP of \>20 mmHg.Percentage of responders achieving a response at the corresponding visit was reported.
Time frame: Baseline, Week 8
Change From Baseline in Plasma Renin Activity (PRA) at Week 8
Time frame: Baseline, week 8
Change From Baseline in Plasma Renin Concentration (PRC) at Week 8
Time frame: Baseline, week 8
Change From Baseline in Plasma Aldosterone at Week 8
Time frame: Baseline, week 8
Number of Patients With Adverse Events, Serious Adverse Events and Death
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Time frame: 8 weeks