NCT01368536

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 975 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Stage 2 Hypertension
• Diabetes

Interventions

Type	Name	Description
DRUG	Valturna	Valturna (aliskiren 150 mg/valsartan 160 mg) tablet
DRUG	Amlodipine	Amlodipine 5 mg and 10 mg capsule
DRUG	Chlorthalidone	Chlorthalidone 15 mg and 25 mg capsule
DRUG	Placebo of Valturna Tablet	Matching placebo of valturna tablet
DRUG	Placebo Capsule	Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-06-08
• Last updated: 2013-03-21
• Results posted: 2013-03-19

Locations

97 sites across 2 countries: United States, Puerto Rico