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HypertensionPhase 4VALENCIANCT01368536

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

A Phase 4 study testing Valturna, Amlodipine and Chlorthalidone in people with Hypertension and Stage 2 Hypertension, run by Novartis Pharmaceuticals at 97 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Stage 2 Hypertension, Diabetes
What is being tested?
Valturna, Amlodipine and Chlorthalidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
975 participants
Where
97 sitesin 2 countries
Study dates
May 2011to Feb 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

97 sites in 2 countries.

97 sites in 2 countries

United States95 sites

  • Novartis Investigative Site

    Arlington, Texas, 76012

  • Novartis Investigative Site

    Arlington, Virginia, 22203

  • Novartis Investigative Site

    Asheboro, North Carolina, 27204

  • Novartis Investigative Site

    Asheville, North Carolina, 28801

  • Novartis Investigative Site

    Athens, Alabama, 35611

  • Novartis Investigative Site

    Augusta, Georgia, 30904

  • Novartis Investigative Site

    Austin, Texas, 78728-6904

  • Novartis Investigative Site

    Austin, Texas, 78735

  • Novartis Investigative Site

    Beltsville, Maine, 20705

  • Novartis Investigative Site

    Belzoni, Mississippi, 39038

  • Novartis Investigative Site

    Brooklyn Center, Minnesota, 55430-2168

  • Novartis Investigative Site

    Buena Park, California, 90620

  • Novartis Investigative Site

    Buffalo, New York, 14209

  • Novartis Investigative Site

    Camillus, New York, 13031

  • Novartis Investigative Site

    Chandler, Arizona, 85224

  • Novartis Investigative Site

    Charleston, South Carolina, 29407

  • Novartis Investigative Site

    Charleston, South Carolina, 29412

  • Novartis Investigative Site

    Chicago, Illinois, 60607

  • Novartis Investigative Site

    Chicago, Illinois, 60610

  • Novartis Investigative Site

    Chicago, Illinois, 60617

  • Novartis Investigative Site

    Cincinnati, Ohio, 45219

  • Novartis Investigative Site

    Cincinnati, Ohio, 45224

  • Novartis Investigative Site

    Columbus, Ohio, 43201

  • Novartis Investigative Site

    Dallas, Texas, 75235

  • Novartis Investigative Site

    Easley, South Carolina, 29640

  • Novartis Investigative Site

    Fair Oaks, California, 95628

  • Novartis Investigative Site

    Fargo, North Dakota, 58103

  • Novartis Investigative Site

    Fayetteville, Tennessee, 33734

  • Novartis Investigative Site

    Florence, Alabama, 35630

  • Novartis Investigative Site

    Fort Lauderdale, Florida, 33306

  • Novartis Investigative Site

    Fort Lauderdale, Florida, 33308

  • Novartis Investigative Site

    Fresno, California, 93726

  • Novartis Investigative Site

    Greensboro, North Carolina, 27401

  • Novartis Investigative Site

    Greensboro, North Carolina, 27408

  • Novartis Investigative Site

    Greenville, South Carolina, 29615

  • Novartis Investigative Site

    Gurnee, Illinois, 60031

  • Novartis Investigative Site

    Healdsburg, California, 95448

  • Novartis Investigative Site

    Henderson, Nevada, 89014

  • Novartis Investigative Site

    Honolulu, Hawaii, 96813

  • Novartis Investigative Site

    Houston, Texas, 77025

  • Novartis Investigative Site

    Houston, Texas, 77074

  • Novartis Investigative Site

    Houston, Texas, 77081

  • Novartis Investigative Site

    Houston, Texas, 77083

  • Novartis Investigative Site

    Huntsville, Alabama, 35801

  • Novartis Investigative Site

    Jackson, Mississippi, 39209

  • Novartis Investigative Site

    Jupiter, Florida, 33458

  • Novartis Investigative Site

    Kansas City, Missouri, 64111

  • Novartis Investigative Site

    Lake Jackson, Texas, 77566

  • Novartis Investigative Site

    Lansing, Kansas, 66043

  • Novartis Investigative Site

    Las Vegas, Nevada, 89119

  • Novartis Investigative Site

    Lauderdale Lakes, Florida, 33319

  • Novartis Investigative Site

    Little Rock, Arkansas, 72204

  • Novartis Investigative Site

    Los Angeles, California, 90057

  • Novartis Investigative Site

    Lyndhurst, Ohio, 44124

  • Novartis Investigative Site

    Montgomery, Alabama, 36106

  • Novartis Investigative Site

    Mt. Pleasant, South Carolina, 29464

  • Novartis Investigative Site

    Muscle Shoals, Alabama, 35662

  • Novartis Investigative Site

    North Miami Beach, Florida, 33169

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73132-4904

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73134

  • Novartis Investigative Site

    Omaha, Nebraska, 68134

  • Novartis Investigative Site

    Orangevale, California, 95662

  • Novartis Investigative Site

    Ozark, Missouri, 65721

  • Novartis Investigative Site

    Pasadena, Texas, 77504

  • Novartis Investigative Site

    Picayune, Mississippi, 39466

  • Novartis Investigative Site

    Plano, Texas, 75093

  • Novartis Investigative Site

    Portland, Oregon, 97232

  • Novartis Investigative Site

    Reading, Pennsylvania, 19609

  • Novartis Investigative Site

    Richardson, Texas, 75080

  • Novartis Investigative Site

    Riverside, California, 92506

  • Novartis Investigative Site

    Roseville, California, 95661

  • Novartis Investigative Site

    Sacramento, California, 95816

  • Novartis Investigative Site

    Santa Ana, California, 92701

  • Novartis Investigative Site

    Shelby, North Carolina, 28150

  • Novartis Investigative Site

    Shelton, Connecticut, 06484

  • Novartis Investigative Site

    St Louis, Missouri, 63110-1093

  • Novartis Investigative Site

    St Louis, Missouri, 63128

  • Novartis Investigative Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    St. George, Utah, 84790

  • Novartis Investigative Site

    St. Petersburg, Florida, 33701

  • Novartis Investigative Site

    Summerville, South Carolina, 29485

  • Novartis Investigative Site

    Tampa, Florida, 33603

  • Novartis Investigative Site

    Toms River, New Jersey, 08753

  • Novartis Investigative Site

    Toms River, New Jersey, 08755

  • Novartis Investigative Site

    Topeka, Kansas, 66606

  • Novartis Investigative Site

    Trenton, New Jersey, 08629

  • Novartis Investigative Site

    Uniontown, Pennsylvania, 15401

  • Novartis Investigative Site

    Varnville, South Carolina, 29944

  • Novartis Investigative Site

    Wallingford, Pennsylvania, 19086

  • Novartis Investigative Site

    Waltham, Massachusetts, 02453

  • Novartis Investigative Site

    Wellesley Hills, Massachusetts, 02481-2106

  • Novartis Investigative Site

    West Covina, California, 91790

  • Novartis Investigative Site

    West Palm Beach, Florida, 33409

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27103

  • Novartis Investigative Site

    Zanesville, Ohio, 43701

Other trials in United States

Puerto Rico2 sites

  • Novartis Investigative Site

    Carolina, 00983

  • Novartis Investigative Site

    San Juan, 00926

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Valturna, Amlodipine, Chlorthalidone, Placebo of Valturna Tablet, Placebo Capsule
Keywords
High blood pressure, diabetes
Medical subject headings
Hypertension, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ValturnaDrug

    Valturna (aliskiren 150 mg/valsartan 160 mg) tablet

  • AmlodipineDrug

    Amlodipine 5 mg and 10 mg capsule

  • ChlorthalidoneDrug

    Chlorthalidone 15 mg and 25 mg capsule

  • Placebo of Valturna TabletDrug

    Matching placebo of valturna tablet

  • Placebo CapsuleDrug

    Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule

Study groups in NCT01368536
Study groupRoleWhat they receive
ValturnaExperimentalAt 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.
Receives: Drug: Valturna; Drug: Placebo of Valturna Tablet; Drug: Placebo Capsule
Valturna + AmlodipineActive comparatorAt 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.
Receives: Drug: Valturna; Drug: Amlodipine; Drug: Placebo of Valturna Tablet; Drug: Placebo Capsule
Valturna + chlorthalidoneActive comparatorAt 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.
Receives: Drug: Valturna; Drug: Chlorthalidone; Drug: Placebo of Valturna Tablet; Drug: Placebo Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 12 weeks

Secondary outcomes (5)

  1. 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.

    Measured: Baseline, 12 weeks

  2. 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.

    Measured: Baseline, 12 weeks

  3. Percentage of Responders After Treatment

    Responders are defined as patients with MSSBP <130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg

    Measured: Baseline, 12 weeks

  4. 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.

    Measured: 12 weeks

  5. 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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Why it stopped: Based on results from an ALTITUDE study interim analysis, testing aliskiren concomitantly with an ACE inhibitor or ARB, in diabetics with renal impairment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
975 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01368536
Sponsor's protocol ID
CSPV100AUS05
Acronym
VALENCIA
Status last verified
Mar 2013
First submitted
6 Jun 2011
Last updated
21 Mar 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Valturna, Amlodipine and Chlorthalidone in people with Hypertension and Stage 2 Hypertension, run by Novartis Pharmaceuticals at 97 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01368536.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2013.

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