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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
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 treatment

Change 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

Page last updated: December 08, 2011

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