MedDataX Logo

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

NCT ID: NCT01368536

Last Updated: 2013-03-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

975 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.

NCT00171561

Hypertension
COMPLETED PHASE4

Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension

NCT00353912

Hypertension
COMPLETED PHASE3

Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus

NCT00927394

Hypertension
COMPLETED PHASE4

Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension.

NCT00409760

Hypertension
COMPLETED PHASE3

Effects of Valsartan and Aliskiren on Hemostatic Indices in Hypertensive Diabetics

NCT01095822

Diabetes Mellitus
UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Stage 2 Hypertension Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Valturna

Intervention Type DRUG

Valturna (aliskiren 150 mg/valsartan 160 mg) tablet

Placebo of Valturna Tablet

Intervention Type DRUG

Matching placebo of valturna tablet

Placebo Capsule

Intervention Type DRUG

Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule

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.

Group Type ACTIVE_COMPARATOR

Valturna

Intervention Type DRUG

Valturna (aliskiren 150 mg/valsartan 160 mg) tablet

Amlodipine

Intervention Type DRUG

Amlodipine 5 mg and 10 mg capsule

Placebo of Valturna Tablet

Intervention Type DRUG

Matching placebo of valturna tablet

Placebo Capsule

Intervention Type DRUG

Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule

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.

Group Type ACTIVE_COMPARATOR

Valturna

Intervention Type DRUG

Valturna (aliskiren 150 mg/valsartan 160 mg) tablet

Chlorthalidone

Intervention Type DRUG

Chlorthalidone 15 mg and 25 mg capsule

Placebo of Valturna Tablet

Intervention Type DRUG

Matching placebo of valturna tablet

Placebo Capsule

Intervention Type DRUG

Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Valturna

Valturna (aliskiren 150 mg/valsartan 160 mg) tablet

Intervention Type DRUG

Amlodipine

Amlodipine 5 mg and 10 mg capsule

Intervention Type DRUG

Chlorthalidone

Chlorthalidone 15 mg and 25 mg capsule

Intervention Type DRUG

Placebo of Valturna Tablet

Matching placebo of valturna tablet

Intervention Type DRUG

Placebo Capsule

Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Athens, Alabama, United States

Site Status

Novartis Investigative Site

Florence, Alabama, United States

Site Status

Novartis Investigative Site

Huntsville, Alabama, United States

Site Status

Novartis Investigative Site

Montgomery, Alabama, United States

Site Status

Novartis Investigative Site

Muscle Shoals, Alabama, United States

Site Status

Novartis Investigative Site

Chandler, Arizona, United States

Site Status

Novartis Investigative Site

Little Rock, Arkansas, United States

Site Status

Novartis Investigative Site

Buena Park, California, United States

Site Status

Novartis Investigative Site

Fair Oaks, California, United States

Site Status

Novartis Investigative Site

Fresno, California, United States

Site Status

Novartis Investigative Site

Healdsburg, California, United States

Site Status

Novartis Investigative Site

Los Angeles, California, United States

Site Status

Novartis Investigative Site

Orangevale, California, United States

Site Status

Novartis Investigative Site

Riverside, California, United States

Site Status

Novartis Investigative Site

Roseville, California, United States

Site Status

Novartis Investigative Site

Sacramento, California, United States

Site Status

Novartis Investigative Site

Santa Ana, California, United States

Site Status

Novartis Investigative Site

West Covina, California, United States

Site Status

Novartis Investigative Site

Shelton, Connecticut, United States

Site Status

Novartis Investigative Site

Fort Lauderdale, Florida, United States

Site Status

Novartis Investigative Site

Fort Lauderdale, Florida, United States

Site Status

Novartis Investigative Site

Jupiter, Florida, United States

Site Status

Novartis Investigative Site

Lauderdale Lakes, Florida, United States

Site Status

Novartis Investigative Site

North Miami Beach, Florida, United States

Site Status

Novartis Investigative Site

St. Petersburg, Florida, United States

Site Status

Novartis Investigative Site

Tampa, Florida, United States

Site Status

Novartis Investigative Site

West Palm Beach, Florida, United States

Site Status

Novartis Investigative Site

Augusta, Georgia, United States

Site Status

Novartis Investigative Site

Honolulu, Hawaii, United States

Site Status

Novartis Investigative Site

Chicago, Illinois, United States

Site Status

Novartis Investigative Site

Chicago, Illinois, United States

Site Status

Novartis Investigative Site

Chicago, Illinois, United States

Site Status

Novartis Investigative Site

Gurnee, Illinois, United States

Site Status

Novartis Investigative Site

Lansing, Kansas, United States

Site Status

Novartis Investigative Site

Topeka, Kansas, United States

Site Status

Novartis Investigative Site

Beltsville, Maine, United States

Site Status

Novartis Investigative Site

Waltham, Massachusetts, United States

Site Status

Novartis Investigative Site

Wellesley Hills, Massachusetts, United States

Site Status

Novartis Investigative Site

Brooklyn Center, Minnesota, United States

Site Status

Novartis Investigative Site

Belzoni, Mississippi, United States

Site Status

Novartis Investigative Site

Jackson, Mississippi, United States

Site Status

Novartis Investigative Site

Picayune, Mississippi, United States

Site Status

Novartis Investigative Site

Kansas City, Missouri, United States

Site Status

Novartis Investigative Site

Ozark, Missouri, United States

Site Status

Novartis Investigative Site

St Louis, Missouri, United States

Site Status

Novartis Investigative Site

St Louis, Missouri, United States

Site Status

Novartis Investigative Site

St Louis, Missouri, United States

Site Status

Novartis Investigative Site

Omaha, Nebraska, United States

Site Status

Novartis Investigative Site

Henderson, Nevada, United States

Site Status

Novartis Investigative Site

Las Vegas, Nevada, United States

Site Status

Novartis Investigative Site

Toms River, New Jersey, United States

Site Status

Novartis Investigative Site

Toms River, New Jersey, United States

Site Status

Novartis Investigative Site

Trenton, New Jersey, United States

Site Status

Novartis Investigative Site

Buffalo, New York, United States

Site Status

Novartis Investigative Site

Camillus, New York, United States

Site Status

Novartis Investigative Site

Asheboro, North Carolina, United States

Site Status

Novartis Investigative Site

Asheville, North Carolina, United States

Site Status

Novartis Investigative Site

Greensboro, North Carolina, United States

Site Status

Novartis Investigative Site

Greensboro, North Carolina, United States

Site Status

Novartis Investigative Site

Shelby, North Carolina, United States

Site Status

Novartis Investigative Site

Winston-Salem, North Carolina, United States

Site Status

Novartis Investigative Site

Fargo, North Dakota, United States

Site Status

Novartis Investigative Site

Cincinnati, Ohio, United States

Site Status

Novartis Investigative Site

Cincinnati, Ohio, United States

Site Status

Novartis Investigative Site

Columbus, Ohio, United States

Site Status

Novartis Investigative Site

Lyndhurst, Ohio, United States

Site Status

Novartis Investigative Site

Zanesville, Ohio, United States

Site Status

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Site Status

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Site Status

Novartis Investigative Site

Portland, Oregon, United States

Site Status

Novartis Investigative Site

Reading, Pennsylvania, United States

Site Status

Novartis Investigative Site

Uniontown, Pennsylvania, United States

Site Status

Novartis Investigative Site

Wallingford, Pennsylvania, United States

Site Status

Novartis Investigative Site

Charleston, South Carolina, United States

Site Status

Novartis Investigative Site

Charleston, South Carolina, United States

Site Status

Novartis Investigative Site

Easley, South Carolina, United States

Site Status

Novartis Investigative Site

Greenville, South Carolina, United States

Site Status

Novartis Investigative Site

Mt. Pleasant, South Carolina, United States

Site Status

Novartis Investigative Site

Summerville, South Carolina, United States

Site Status

Novartis Investigative Site

Varnville, South Carolina, United States

Site Status

Novartis Investigative Site

Fayetteville, Tennessee, United States

Site Status

Novartis Investigative Site

Arlington, Texas, United States

Site Status

Novartis Investigative Site

Austin, Texas, United States

Site Status

Novartis Investigative Site

Austin, Texas, United States

Site Status

Novartis Investigative Site

Dallas, Texas, United States

Site Status

Novartis Investigative Site

Houston, Texas, United States

Site Status

Novartis Investigative Site

Houston, Texas, United States

Site Status

Novartis Investigative Site

Houston, Texas, United States

Site Status

Novartis Investigative Site

Houston, Texas, United States

Site Status

Novartis Investigative Site

Lake Jackson, Texas, United States

Site Status

Novartis Investigative Site

Pasadena, Texas, United States

Site Status

Novartis Investigative Site

Plano, Texas, United States

Site Status

Novartis Investigative Site

Richardson, Texas, United States

Site Status

Novartis Investigative Site

St. George, Utah, United States

Site Status

Novartis Investigative Site

Arlington, Virginia, United States

Site Status

Novartis Investigative Site

Carolina, , Puerto Rico

Site Status

Novartis Investigative Site

San Juan, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSPV100AUS05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Patients With Stage II Hypertension
NCT00350168 COMPLETED PHASE3
Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy
NCT00351130 COMPLETED PHASE4
Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension
NCT00333489 COMPLETED PHASE4
Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension
NCT00931710 COMPLETED PHASE4
Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
NCT00523744 COMPLETED PHASE3
Effectiveness of a Valsartan Based Versus an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy
NCT00304226 COMPLETED PHASE4
Comparison of Amlodipine and Aliskiren in Diabetic Hypertensive Patient With Blood Pressure Not Controlled by Losartan
NCT01409408 WITHDRAWN PHASE4
Efficacy and Safety of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension
NCT00437645 COMPLETED PHASE3
Efficacy and Safety of Valsartan/Amlodipine Combination in Patients With Severe Hypertension
NCT00171535 COMPLETED PHASE3
Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine
NCT00367939 COMPLETED PHASE3
A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension
NCT00170976 COMPLETED PHASE3
Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Amlodipine Alone
NCT00171002 COMPLETED PHASE3
A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy
NCT01241487 COMPLETED PHASE4
Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients
NCT00409643 COMPLETED PHASE3
Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)
NCT00446524 COMPLETED PHASE3
A Study to Evaluate the Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled on Monotherapy
NCT00327145 COMPLETED PHASE3
The Drug-drug Interaction of SP2086 and Valsartan
NCT02815657 COMPLETED PHASE1
Valsartan and Amlodipine in Blood Pressure Management: Fixed-Dose vs. Free Drug Therapy
NCT06487949 COMPLETED PHASE4
A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People
NCT01259297 TERMINATED PHASE3
Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension
NCT00413049 COMPLETED PHASE3
Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Valsartan Alone
NCT00170963 COMPLETED PHASE3
A 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia
NCT00171093 COMPLETED PHASE3
A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients
NCT00219102 COMPLETED PHASE3
Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension
NCT00171054 COMPLETED PHASE4
One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension
NCT00409851 COMPLETED PHASE3