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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

NCT01368536 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 975

Last updated 2013-03-21

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01368536 on ClinicalTrials.gov