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
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Stage 2 Hypertension; Diabetes
Intervention: Valturna + amlodipine (Drug); valturna + placebo (Drug); Valturna + chlorthalidone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact:
Novartis Pharmaceuticals, Phone: 862-778-8300
Summary
This is 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 BP (MSSBP)after 12 weeks of treatment
Secondary outcome: change from baseline in MSSBP after 12 weeks of treatmentChange from baseline in mean sitting diastolic BP (MSDBP) after 12 weeks of treatment Percentage of responders after treatment Evaluate 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 Pharmaceuticals, Phone: 862-778-8300
Investigative Site, Carolina 00983, Puerto Rico; Recruiting
Noemi Maldonado, Phone: 787 776 6000, Email: fcrnmaldonado@gmail.com
Investigative Site, Fair Oaks, California 95628, United States; Recruiting
Susan Mullins, Phone: 916-966-7452
Investigative Site, Healdsburg, California 95448, United States; Recruiting
Lindsay Canavero, Phone: 707-431-9181, Email: lcanavero20@yahoo.com
Investigative Site, Santa Ana, California 92701, United States; Recruiting
Maria Luna, Phone: 714-550-0663, Email: lunam3@gmail.co
Investigative Site, Shelton, Connecticut 06484, United States; Recruiting
Jimmie Thomas, Phone: 203-944-9775, Email: jthegendarme@aol.com
Investigative Site, St. Petersburg,, Florida 33701, United States; Recruiting
Miriam Curran, Phone: 727-824-3108, Email: miriamcurran@gmail.com
Investigative Site, Honolulu, Hawaii 96813, United States; Recruiting
Robin Yamamoto, Phone: 808-587-8605, Email: robinewy@hawaii.edu
Investigative Site, Chicago, Illinois, United States; Recruiting
David Dayon, Phone: 773-978-5671
Investigative Site, Topeka, Kansas 66606, United States; Recruiting
Michelle Kipp, Email: mikipp@stormontvail.org
Investigative Site, Beltsville, Maine 20705, United States; Recruiting
Anne Marie Cobb, Phone: 202-904-8599, Email: acobb@metresearch.org
Investigative Site, Waltham, Massachusetts 02453, United States; Recruiting
Elizabeth Taylor, Phone: 781-647-7200, Email: etaylor@massresearch.com
Investigative Site, Toms River, New Jersey 08753, United States; Recruiting
Patricia Haws, Phone: 732-600-4742
Investigative Site, Zanesville, Ohio, United States; Recruiting
Carma Ross, Phone: 740-453-7555
Investigative Site, Austin, Texas 78728, United States; Recruiting
Patricia Lewis, Phone: 512-990-9004, Email: palewis08@sbcglobal.net
Investigative Site, Austin, Texas, United States; Recruiting
Debbie Dawson, Email: drdawson@austin.rr.com
Investigative Site, Dallas, Texas, United States; Recruiting
Manuela Reed, Phone: 214-638-1773
Investigator Site, Kenosha, Wisconsin 53142, United States; Recruiting
Christina Benton, Phone: 262-925-1280, Email: cbenton@cisresearch.com
Additional Information
Starting date: May 2011
Last updated: June 7, 2011
|
