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Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension

NCT00699192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 965

Last updated 2011-06-06

Study results available
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Summary

To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.

Conditions

Interventions

DRUG

Amlodipine 5 mg

1 capsule amlodipine 5 mg orally once daily

DRUG

Valsartan 80 mg

1 capsule valsartan 80 mg orally once daily

DRUG

Valsartan 40 mg

1 capsule valsartan 40 mg orally once daily

DRUG

Placebo

1 capsule placebo to match valsartan orally once daily

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Slovakia
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
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 NCT00699192 on ClinicalTrials.gov