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

Hypertension Clinical Trial

— VALENCIA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01368536
• Other study ID #: CSPV100AUS05
• Status: Terminated
• Phase: Phase 4
• First received: June 6, 2011
• Last updated: March 18, 2013
• Start date: May 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 975
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypertension
• Stage 2 Hypertension

Intervention

Drug:
• Valturna
Valturna (aliskiren 150 mg/valsartan 160 mg) tablet
• Amlodipine
Amlodipine 5 mg and 10 mg capsule
• Chlorthalidone
Chlorthalidone 15 mg and 25 mg capsule
• Placebo of Valturna Tablet
Matching placebo of valturna tablet
• Placebo Capsule
Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule

Locations

Country	Name	City	State
Puerto Rico	Novartis Investigative Site	Carolina
Puerto Rico	Novartis Investigative Site	San Juan
United States	Novartis Investigative Site	Arlington	Virginia
United States	Novartis Investigative Site	Arlington	Texas
United States	Novartis Investigative Site	Asheboro	North Carolina
United States	Novartis Investigative Site	Asheville	North Carolina
United States	Novartis Investigative Site	Athens	Alabama
United States	Novartis Investigative Site	Augusta	Georgia
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Beltsville	Maine
United States	Novartis Investigative Site	Belzoni	Mississippi
United States	Novartis Investigative Site	Brooklyn Center	Minnesota
United States	Novartis Investigative Site	Buena Park	California
United States	Novartis Investigative Site	Buffalo	New York
United States	Novartis Investigative Site	Camillus	New York
United States	Novartis Investigative Site	Chandler	Arizona
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Chicago	Illinois
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Easley	South Carolina
United States	Novartis Investigative Site	Fair Oaks	California
United States	Novartis Investigative Site	Fargo	North Dakota
United States	Novartis Investigative Site	Fayetteville	Tennessee
United States	Novartis Investigative Site	Florence	Alabama
United States	Novartis Investigative Site	Fort Lauderdale	Florida
United States	Novartis Investigative Site	Fresno	California
United States	Novartis Investigative Site	Ft. Lauderdale	Florida
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Greensboro	North Carolina
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigative Site	Gurnee	Illinois
United States	Novartis Investigative Site	Healdsburg	California
United States	Novartis Investigative Site	Henderson	Nevada
United States	Novartis Investigative Site	Honolulu	Hawaii
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Huntsville	Alabama
United States	Novartis Investigative Site	Jackson	Mississippi
United States	Novartis Investigative Site	Jupiter	Florida
United States	Novartis Investigative Site	Kansas City	Missouri
United States	Novartis Investigative Site	Lake Jackson	Texas
United States	Novartis Investigative Site	Lansing	Kansas
United States	Novartis Investigative Site	Las Vegas	Nevada
United States	Novartis Investigative Site	Lauderdale Lakes	Florida
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Lyndhurst	Ohio
United States	Novartis Investigative Site	Montgomery	Alabama
United States	Novartis Investigative Site	Mt. Pleasant	South Carolina
United States	Novartis Investigative Site	Muscle Shoals	Alabama
United States	Novartis Investigative Site	North Miami Beach	Florida
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Orangevale	California
United States	Novartis Investigative Site	Ozark	Missouri
United States	Novartis Investigative Site	Pasadena	Texas
United States	Novartis Investigative Site	Picayune	Mississippi
United States	Novartis Investigative Site	Plano	Texas
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Reading	Pennsylvania
United States	Novartis Investigative Site	Richardson	Texas
United States	Novartis Investigative Site	Riverside	California
United States	Novartis Investigative Site	Roseville	California
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	Santa Ana	California
United States	Novartis Investigative Site	Shelby	North Carolina
United States	Novartis Investigative Site	Shelton	Connecticut
United States	Novartis Investigative Site	St. George	Utah
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	St. Petersburg	Florida
United States	Novartis Investigative Site	Summerville	South Carolina
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Toms River	New Jersey
United States	Novartis Investigative Site	Toms River	New Jersey
United States	Novartis Investigative Site	Topeka	Kansas
United States	Novartis Investigative Site	Trenton	New Jersey
United States	Novartis Investigative Site	Uniontown	Pennsylvania
United States	Novartis Investigative Site	Varnville	South Carolina
United States	Novartis Investigative Site	Wallingford	Pennsylvania
United States	Novartis Investigative Site	Waltham	Massachusetts
United States	Novartis Investigative Site	Wellesley Hills	Massachusetts
United States	Novartis Investigative Site	West Covina	California
United States	Novartis Investigative Site	West Palm Beach	Florida
United States	Novartis Investigative Site	Winston-Salem	North Carolina
United States	Novartis Investigative Site	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes