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26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension

NCT00624052 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 838

Last updated 2014-05-20

Study results available
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Summary

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months.

An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.

The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP \< 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).

Conditions

Interventions

DRUG

fixed-dose combination of telmisartan 40mg+amlodipine 10mg

DRUG

fixed-dose combination of telmisartan 80mg+amlodipine10mg

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-06-30

Countries

  • Australia
  • Austria
  • Bulgaria
  • Czechia
  • Ireland
  • Italy
  • New Zealand
  • Russia
  • Slovakia
  • Spain
  • Ukraine
  • United Kingdom

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 NCT00624052 on ClinicalTrials.gov