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

• Status: Terminated
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Amlodipine; Chlorthalidone

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