Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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A 12-week, Multi-Center, Randomized Double-Blind, Active Control Parallel Group Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes

Conditions
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Hypertension, Stage 2 Hypertension, Diabetes

Intervention / Treatment
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* Drug: Valturna
* Drug: Amlodipine
* Drug: Chlorthalidone
* Drug: Placebo of Valturna Tablet
* Drug: Placebo Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stage 2 hypertension within protocol limits at randomization Patients with type 2 diabetes mellitus with HgA1c less than or equal to 9% Patients with newly diagnosed hypertension or patients who have not received antihypertensive therapy for at least 4 weeks prior to screening Exclusion Criteria: Patients taking 4 or more antihypertensive medications at screening visit Patients with uncontrolled BP (> 140/90 mmHg) while taking 3 or more antihypertensives at their maximum approved doses Type 2 diabetes mellitus requiring insulin treatment Patients with HgA1c > 9% Patients with known gout Known history of cancer within the past 5 years Patients who are pregnant or nursing mothers Patients who have participated in an investigational clinical trial within the 30 days prior to screening. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valturna<br>At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks. | Drug: Valturna<br>* Valturna (aliskiren 150 mg/valsartan 160 mg) tablet<br>Drug: Placebo of Valturna Tablet<br>* Matching placebo of valturna tablet<br>Drug: Placebo Capsule<br>* Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule<br>|
| Active Comparator: Valturna + Amlodipine<br>At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks. | Drug: Valturna<br>* Valturna (aliskiren 150 mg/valsartan 160 mg) tablet<br>Drug: Amlodipine<br>* Amlodipine 5 mg and 10 mg capsule<br>Drug: Placebo of Valturna Tablet<br>* Matching placebo of valturna tablet<br>Drug: Placebo Capsule<br>* Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule<br>|
| Active Comparator: Valturna + chlorthalidone<br>At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks. | Drug: Valturna<br>* Valturna (aliskiren 150 mg/valsartan 160 mg) tablet<br>Drug: Chlorthalidone<br>* Chlorthalidone 15 mg and 25 mg capsule<br>Drug: Placebo of Valturna Tablet<br>* Matching placebo of valturna tablet<br>Drug: Placebo Capsule<br>* Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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. | 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 |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, High blood pressure