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)

March 18, 2013 updated by: Novartis Pharmaceuticals

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
975

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Baseline, 12 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Baseline, 12 weeks
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
Time Frame: Baseline, 12 weeks
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
Time Frame: Baseline, 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSPV100AUS05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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