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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Hypertension, Stage 2 Hypertension, Diabetes

In brief

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.

Key facts

Study ID

NCT01368536

Run by

Novartis Pharmaceuticals

People needed

975

Starts

2011-05-01

Expected to finish

2012-02-01

Last updated by the study team

2013-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Florence, Alabama, United States
• Novartis Investigative Site — Huntsville, Alabama, United States
• Novartis Investigative Site — Montgomery, Alabama, United States
• Novartis Investigative Site — Muscle Shoals, Alabama, United States
• Novartis Investigative Site — Chandler, Arizona, United States
• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Buena Park, California, United States
• Novartis Investigative Site — Fair Oaks, California, United States
• Novartis Investigative Site — Fresno, California, United States
• Novartis Investigative Site — Healdsburg, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Orangevale, California, 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 — West Covina, California, United States
• Novartis Investigative Site — Shelton, Connecticut, United States
• Novartis Investigative Site — Fort Lauderdale, Florida, United States
• Novartis Investigative Site — Fort Lauderdale, Florida, United States
• Novartis Investigative Site — Jupiter, Florida, United States
• Novartis Investigative Site — Lauderdale Lakes, Florida, United States
• Novartis Investigative Site — North Miami Beach, Florida, United States
• Novartis Investigative Site — St. Petersburg, Florida, United States
• Novartis Investigative Site — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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