Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension

NCT00931710 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2011-03-07

Study results available
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Summary

This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

Conditions

  • Stage 2 Systolic Hypertension

Interventions

DRUG

valsartan, amlodipine, HCTZ

combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study

DRUG

Losartan, HCTZ followed by valsartan, amlodipine, HCTZ

losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCTZ 25 mg capsule for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (3 weeks) of the study

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · 862-778-8300

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Entities

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 NCT00931710 on ClinicalTrials.gov