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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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Stage 2 Hypertension; Diabetes

Intervention: Valturna (Drug); Amlodipine (Drug); Chlorthalidone (Drug); Placebo of Valturna Tablet (Drug); Placebo Capsule (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

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

Primary outcome: 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

Secondary outcome:

Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment

Percentage of Responders After Treatment

Percentage of Patients Achieving Blood Pressure Control After Treatment

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Novartis Investigative Site, Carolina 00983, Puerto Rico

Novartis Investigative Site, San Juan 00926, Puerto Rico

Novartis Investigative Site, Athens, Alabama 35611, United States

Novartis Investigative Site, Florence, Alabama 35630, United States

Novartis Investigative Site, Huntsville, Alabama 35801, United States

Novartis Investigative Site, Montgomery, Alabama 36106, United States

Novartis Investigative Site, Muscle Shoals, Alabama 35662, United States

Novartis Investigative Site, Chandler, Arizona 85224, United States

Novartis Investigative Site, Little Rock, Arkansas 72204, United States

Novartis Investigative Site, Buena Park, California 90620, United States

Novartis Investigative Site, Fair Oaks, California 95628, United States

Novartis Investigative Site, Fresno, California 93726, United States

Novartis Investigative Site, Healdsburg, California 95448, United States

Novartis Investigative Site, Los Angeles, California 90057, United States

Novartis Investigative Site, Orangevale, California 95662, United States

Novartis Investigative Site, Riverside, California 92506, United States

Novartis Investigative Site, Roseville, California 95661, United States

Novartis Investigative Site, Sacramento, California 95816, United States

Novartis Investigative Site, Santa Ana, California 92701, United States

Novartis Investigative Site, West Covina, California 91790, United States

Novartis Investigative Site, Shelton, Connecticut 06484, United States

Novartis Investigative Site, Fort Lauderdale, Florida 33306, United States

Novartis Investigative Site, Ft. Lauderdale, Florida 33308, United States

Novartis Investigative Site, Jupiter, Florida 33458, United States

Novartis Investigative Site, Lauderdale Lakes, Florida 33319, United States

Novartis Investigative Site, North Miami Beach, Florida 33169, United States

Novartis Investigative Site, St. Petersburg, Florida 33701, United States

Novartis Investigative Site, Tampa, Florida 33603, United States

Novartis Investigative Site, West Palm Beach, Florida 33409, United States

Novartis Investigative Site, Augusta, Georgia 30904, United States

Novartis Investigative Site, Honolulu, Hawaii 96813, United States

Novartis Investigative Site, Chicago, Illinois 60607, United States

Novartis Investigative Site, Chicago, Illinois 60610, United States

Novartis Investigative Site, Chicago, Illinois 60617, United States

Novartis Investigative Site, Gurnee, Illinois 60031, United States

Novartis Investigative Site, Lansing, Kansas 66043, United States

Novartis Investigative Site, Topeka, Kansas 66606, United States

Novartis Investigative Site, Beltsville, Maine 20705, United States

Novartis Investigative Site, Waltham, Massachusetts 02453, United States

Novartis Investigative Site, Wellesley Hills, Massachusetts 02481-2106, United States

Novartis Investigative Site, Brooklyn Center, Minnesota 55430-2168, United States

Novartis Investigative Site, Belzoni, Mississippi 39038, United States

Novartis Investigative Site, Jackson, Mississippi 39209, United States

Novartis Investigative Site, Picayune, Mississippi 39466, United States

Novartis Investigative Site, Kansas City, Missouri 64111, United States

Novartis Investigative Site, Ozark, Missouri 65721, United States

Novartis Investigative Site, St. Louis, Missouri 63110-1093, United States

Novartis Investigative Site, St. Louis, Missouri 63128, United States

Novartis Investigative Site, St. Louis, Missouri 63141, United States

Novartis Investigative Site, Omaha, Nebraska 68134, United States

Novartis Investigative Site, Henderson, Nevada 89014, United States

Novartis Investigative Site, Las Vegas, Nevada 89119, United States

Novartis Investigative Site, Toms River, New Jersey 08753, United States

Novartis Investigative Site, Toms River, New Jersey 08755, United States

Novartis Investigative Site, Trenton, New Jersey 08629, United States

Novartis Investigative Site, Buffalo, New York 14209, United States

Novartis Investigative Site, Camillus, New York 13031, United States

Novartis Investigative Site, Asheboro, North Carolina 27204, United States

Novartis Investigative Site, Asheville, North Carolina 28801, United States

Novartis Investigative Site, Greensboro, North Carolina 27401, United States

Novartis Investigative Site, Greensboro, North Carolina 27408, United States

Novartis Investigative Site, Shelby, North Carolina 28150, United States

Novartis Investigative Site, Winston-Salem, North Carolina 27103, United States

Novartis Investigative Site, Fargo, North Dakota 58103, United States

Novartis Investigative Site, Cincinnati, Ohio 45224, United States

Novartis Investigative Site, Cincinnati, Ohio 45219, United States

Novartis Investigative Site, Columbus, Ohio 43201, United States

Novartis Investigative Site, Lyndhurst, Ohio 44124, United States

Novartis Investigative Site, Zanesville, Ohio 43701, United States

Novartis Investigative Site, Oklahoma City, Oklahoma 73132-4904, United States

Novartis Investigative Site, Oklahoma City, Oklahoma 73134, United States

Novartis Investigative Site, Portland, Oregon 97232, United States

Novartis Investigative Site, Reading, Pennsylvania 19609, United States

Novartis Investigative Site, Uniontown, Pennsylvania 15401, United States

Novartis Investigative Site, Wallingford, Pennsylvania 19086, United States

Novartis Investigative Site, Charleston, South Carolina 29407, United States

Novartis Investigative Site, Charleston, South Carolina 29412, United States

Novartis Investigative Site, Easley, South Carolina 29640, United States

Novartis Investigative Site, Greenville, South Carolina 29615, United States

Novartis Investigative Site, Mt. Pleasant, South Carolina 29464, United States

Novartis Investigative Site, Summerville, South Carolina 29485, United States

Novartis Investigative Site, Varnville, South Carolina 29944, United States

Novartis Investigative Site, Fayetteville, Tennessee 33734, United States

Novartis Investigative Site, Arlington, Texas 76012, United States

Novartis Investigative Site, Austin, Texas 78728-6904, United States

Novartis Investigative Site, Austin, Texas 78735, United States

Novartis Investigative Site, Dallas, Texas 75235, United States

Novartis Investigative Site, Houston, Texas 77083, United States

Novartis Investigative Site, Houston, Texas 77074, United States

Novartis Investigative Site, Houston, Texas 77081, United States

Novartis Investigative Site, Houston, Texas 77025, United States

Novartis Investigative Site, Lake Jackson, Texas 77566, United States

Novartis Investigative Site, Pasadena, Texas 77504, United States

Novartis Investigative Site, Plano, Texas 75093, United States

Novartis Investigative Site, Richardson, Texas 75080, United States

Novartis Investigative Site, St. George, Utah 84790, United States

Novartis Investigative Site, Arlington, Virginia 22203, United States

Additional Information

Starting date: May 2011
Last updated: March 18, 2013

Page last updated: August 23, 2015

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