Clinical trial NCT01368536: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension
Stage 2 Hypertension
Diabetes
Keywords: High blood pressure
diabetes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 975
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment
timeFrame: Baseline, 12 weeks
measure: Percentage of Responders After Treatment
timeFrame: Baseline, 12 weeks
measure: Percentage of Patients Achieving Blood Pressure Control After Treatment
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Athens
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Florence
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Huntsville
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Montgomery
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Muscle Shoals
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Chandler
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Little Rock
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Buena Park
country: United States
facility: Novartis Investigative Site
state: California
city: Fair Oaks
country: United States
facility: Novartis Investigative Site
state: California
city: Fresno
country: United States
facility: Novartis Investigative Site
state: California
city: Healdsburg
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Orangevale
country: United States
facility: Novartis Investigative Site
state: California
city: Riverside
country: United States
facility: Novartis Investigative Site
state: California
city: Roseville
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: Santa Ana
country: United States
facility: Novartis Investigative Site
state: California
city: West Covina
country: United States
facility: Novartis Investigative Site
state: California
city: Shelton
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Novartis Investigative Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Novartis Investigative Site
state: Florida
city: Jupiter
country: United States
facility: Novartis Investigative Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Novartis Investigative Site
state: Florida
city: North Miami Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: St. Petersburg
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Augusta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Honolulu
country: United States
facility: Novartis Investigative Site
state: Hawaii
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Gurnee
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Lansing
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Beltsville
country: United States
facility: Novartis Investigative Site
state: Maine
city: Waltham
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Wellesley Hills
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Brooklyn Center
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Belzoni
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Picayune
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Kansas City
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Ozark
country: United States
facility: Novartis Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Henderson
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Toms River
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Toms River
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Trenton
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Buffalo
country: United States
facility: Novartis Investigative Site
state: New York
city: Camillus
country: United States
facility: Novartis Investigative Site
state: New York
city: Asheboro
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Asheville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Shelby
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Fargo
country: United States
facility: Novartis Investigative Site
state: North Dakota
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Lyndhurst
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Zanesville
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Reading
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Uniontown
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Wallingford
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Easley
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Greenville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Summerville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Varnville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Fayetteville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Texas
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Lake Jackson
country: United States
facility: Novartis Investigative Site
state: Texas
city: Pasadena
country: United States
facility: Novartis Investigative Site
state: Texas
city: Plano
country: United States
facility: Novartis Investigative Site
state: Texas
city: Richardson
country: United States
facility: Novartis Investigative Site
state: Texas
city: St. George
country: United States
facility: Novartis Investigative Site
state: Utah
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Carolina
country: Puerto Rico
facility: Novartis Investigative Site
city: San Juan
country: Puerto Rico
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: