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 (VALENCIA)

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

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 Overview

• Status: Terminated
• Conditions: Hypertension; Diabetes; Stage 2 Hypertension
• Intervention / Treatment: Drug: Valturna; Drug: Placebo of Valturna Tablet; Drug: Placebo Capsule; Drug: Amlodipine; Drug: Chlorthalidone

• Study Type: Interventional
• Enrollment (Actual): 975
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • Carolina, Puerto Rico, 00983
    • Novartis Investigative Site
  • San Juan, Puerto Rico, 00926
    • Novartis Investigative Site
• United States
  • Alabama
    • Athens, Alabama, United States, 35611
      • Novartis Investigative Site
    • Florence, Alabama, United States, 35630
      • Novartis Investigative Site
    • Huntsville, Alabama, United States, 35801
      • Novartis Investigative Site
    • Montgomery, Alabama, United States, 36106
      • Novartis Investigative Site
    • Muscle Shoals, Alabama, United States, 35662
      • Novartis Investigative Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Novartis Investigative Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Novartis Investigative Site
  • California
    • Buena Park, California, United States, 90620
      • Novartis Investigative Site
    • Fair Oaks, California, United States, 95628
      • Novartis Investigative Site
    • Fresno, California, United States, 93726
      • Novartis Investigative Site
    • Healdsburg, California, United States, 95448
      • Novartis Investigative Site
    • Los Angeles, California, United States, 90057
      • Novartis Investigative Site
    • Orangevale, California, United States, 95662
      • Novartis Investigative Site
    • Riverside, California, United States, 92506
      • Novartis Investigative Site
    • Roseville, California, United States, 95661
      • Novartis Investigative Site
    • Sacramento, California, United States, 95816
      • Novartis Investigative Site
    • Santa Ana, California, United States, 92701
      • Novartis Investigative Site
    • West Covina, California, United States, 91790
      • Novartis Investigative Site
  • Connecticut
    • Shelton, Connecticut, United States, 06484
      • Novartis Investigative Site
  • Florida
    • Fort Lauderdale, Florida, United States, 33306
      • Novartis Investigative Site
    • Ft. Lauderdale, Florida, United States, 33308
      • Novartis Investigative Site
    • Jupiter, Florida, United States, 33458
      • Novartis Investigative Site
    • Lauderdale Lakes, Florida, United States, 33319
      • Novartis Investigative Site
    • North Miami Beach, Florida, United States, 33169
      • Novartis Investigative Site
    • St. Petersburg, Florida, United States, 33701
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33603
      • Novartis Investigative Site
    • West Palm Beach, Florida, United States, 33409
      • Novartis Investigative Site
  • Georgia
    • Augusta, Georgia, United States, 30904
      • Novartis Investigative Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Novartis Investigative Site
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Novartis Investigative Site
    • Chicago, Illinois, United States, 60610
      • Novartis Investigative Site
    • Chicago, Illinois, United States, 60617
      • Novartis Investigative Site
    • Gurnee, Illinois, United States, 60031
      • Novartis Investigative Site
  • Kansas
    • Lansing, Kansas, United States, 66043
      • Novartis Investigative Site
    • Topeka, Kansas, United States, 66606
      • Novartis Investigative Site
  • Maine
    • Beltsville, Maine, United States, 20705
      • Novartis Investigative Site
  • Massachusetts
    • Waltham, Massachusetts, United States, 02453
      • Novartis Investigative Site
    • Wellesley Hills, Massachusetts, United States, 02481-2106
      • Novartis Investigative Site
  • Minnesota
    • Brooklyn Center, Minnesota, United States, 55430-2168
      • Novartis Investigative Site
  • Mississippi
    • Belzoni, Mississippi, United States, 39038
      • Novartis Investigative Site
    • Jackson, Mississippi, United States, 39209
      • Novartis Investigative Site
    • Picayune, Mississippi, United States, 39466
      • Novartis Investigative Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Novartis Investigative Site
    • Ozark, Missouri, United States, 65721
      • Novartis Investigative Site
    • St. Louis, Missouri, United States, 63128
      • Novartis Investigative Site
    • St. Louis, Missouri, United States, 63141
      • Novartis Investigative Site
    • St. Louis, Missouri, United States, 63110-1093
      • Novartis Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Novartis Investigative Site
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Novartis Investigative Site
    • Las Vegas, Nevada, United States, 89119
      • Novartis Investigative Site
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Novartis Investigative Site
    • Toms River, New Jersey, United States, 08753
      • Novartis Investigative Site
    • Trenton, New Jersey, United States, 08629
      • Novartis Investigative Site
  • New York
    • Buffalo, New York, United States, 14209
      • Novartis Investigative Site
    • Camillus, New York, United States, 13031
      • Novartis Investigative Site
  • North Carolina
    • Asheboro, North Carolina, United States, 27204
      • Novartis Investigative Site
    • Asheville, North Carolina, United States, 28801
      • Novartis Investigative Site
    • Greensboro, North Carolina, United States, 27401
      • Novartis Investigative Site
    • Greensboro, North Carolina, United States, 27408
      • Novartis Investigative Site
    • Shelby, North Carolina, United States, 28150
      • Novartis Investigative Site
    • Winston-Salem, North Carolina, United States, 27103
      • Novartis Investigative Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Novartis Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Novartis Investigative Site
    • Cincinnati, Ohio, United States, 45224
      • Novartis Investigative Site
    • Columbus, Ohio, United States, 43201
      • Novartis Investigative Site
    • Lyndhurst, Ohio, United States, 44124
      • Novartis Investigative Site
    • Zanesville, Ohio, United States, 43701
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73134
      • Novartis Investigative Site
    • Oklahoma City, Oklahoma, United States, 73132-4904
      • Novartis Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97232
      • Novartis Investigative Site
  • Pennsylvania
    • Reading, Pennsylvania, United States, 19609
      • Novartis Investigative Site
    • Uniontown, Pennsylvania, United States, 15401
      • Novartis Investigative Site
    • Wallingford, Pennsylvania, United States, 19086
      • Novartis Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Novartis Investigative Site
    • Charleston, South Carolina, United States, 29412
      • Novartis Investigative Site
    • Easley, South Carolina, United States, 29640
      • Novartis Investigative Site
    • Greenville, South Carolina, United States, 29615
      • Novartis Investigative Site
    • Mt. Pleasant, South Carolina, United States, 29464
      • Novartis Investigative Site
    • Summerville, South Carolina, United States, 29485
      • Novartis Investigative Site
    • Varnville, South Carolina, United States, 29944
      • Novartis Investigative Site
  • Tennessee
    • Fayetteville, Tennessee, United States, 33734
      • Novartis Investigative Site
  • Texas
    • Arlington, Texas, United States, 76012
      • Novartis Investigative Site
    • Austin, Texas, United States, 78728-6904
      • Novartis Investigative Site
    • Austin, Texas, United States, 78735
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75235
      • Novartis Investigative Site
    • Houston, Texas, United States, 77025
      • Novartis Investigative Site
    • Houston, Texas, United States, 77074
      • Novartis Investigative Site
    • Houston, Texas, United States, 77081
      • Novartis Investigative Site
    • Houston, Texas, United States, 77083
      • Novartis Investigative Site
    • Lake Jackson, Texas, United States, 77566
      • Novartis Investigative Site
    • Pasadena, Texas, United States, 77504
      • Novartis Investigative Site
    • Plano, Texas, United States, 75093
      • Novartis Investigative Site
    • Richardson, Texas, United States, 75080
      • Novartis Investigative Site
  • Utah
    • St. George, Utah, United States, 84790
      • Novartis Investigative Site
  • Virginia
    • Arlington, Virginia, United States, 22203
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Valturna; 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; Valturna (aliskiren 150 mg/valsartan 160 mg) tablet; Drug: Placebo of Valturna Tablet; Matching placebo of valturna tablet; Drug: Placebo Capsule; Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule
Active Comparator: Valturna + Amlodipine; 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; Valturna (aliskiren 150 mg/valsartan 160 mg) tablet; Drug: Placebo of Valturna Tablet; Matching placebo of valturna tablet; Drug: Placebo Capsule; Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule; Drug: Amlodipine; Amlodipine 5 mg and 10 mg capsule
Active Comparator: Valturna + chlorthalidone; 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; Valturna (aliskiren 150 mg/valsartan 160 mg) tablet; Drug: Placebo of Valturna Tablet; Matching placebo of valturna tablet; Drug: Placebo Capsule; Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule; Drug: Chlorthalidone; Chlorthalidone 15 mg and 25 mg capsule

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Estimate): March 21, 2013
• Last Update Submitted That Met QC Criteria: March 18, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: diabetes; High blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hypertension; Diabetes Mellitus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Sodium Chloride Symporter Inhibitors; Amlodipine; Chlorthalidone
• Other Study ID Numbers: CSPV100AUS05