This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and diabetes mellitus 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
975
Valturna (aliskiren 150 mg/valsartan 160 mg) tablet
Amlodipine 5 mg and 10 mg capsule
Chlorthalidone 15 mg and 25 mg capsule
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) After 12 Weeks of Treatment Ending With the Combination of Valturna and Amlodipine Versus Valturna Alone
Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
Time frame: Baseline, 12 weeks
Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone
Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
Time frame: Baseline, 12 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment
Sitting blood pressure (BP) was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
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Matching placebo of valturna tablet
Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule
Novartis Investigative Site
Athens, Alabama, United States
Novartis Investigative Site
Florence, Alabama, United States
Novartis Investigative Site
Huntsville, Alabama, United States
Novartis Investigative Site
Montgomery, Alabama, United States
Novartis Investigative Site
Muscle Shoals, Alabama, United States
Novartis Investigative Site
Chandler, Arizona, United States
Novartis Investigative Site
Little Rock, Arkansas, United States
Novartis Investigative Site
Buena Park, California, United States
Novartis Investigative Site
Fair Oaks, California, United States
Novartis Investigative Site
Fresno, California, United States
...and 87 more locations
Time frame: Baseline, 12 weeks
Percentage of Responders After Treatment
Responders are defined as patients with MSSBP \<130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg
Time frame: Baseline, 12 weeks
Percentage of Patients Achieving Blood Pressure Control After Treatment
Patient with blood pressure control is defined as patients achieving MSSBP \<130 mmHg and MSDBP \<80 mmHg.
Time frame: 12 weeks
Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone
Time frame: 12 weeks