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Study Evaluating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control.

NCT00750113 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2014-12-05

No results posted yet for this study

Summary

Patients having uncontrolled or poorly controlled hypertension are at risk of experiencing cardiovascular events such as myocardial infarction or stroke. To reduce this risk an appropriate antihypertensive therapy should allow to reach a target blood pressure of less than 130/80 mmHg in order to maximise cardiovascular protection.The purpose of this study is to evaluate the efficacy in blood pressure control when anti-hypertensive therapy is initiated with a combination of low dose Nifedipine GITS and Telmisartan compared to a regimen starting with monotherapy before adding the other drug.The primary efficacy parameter will be the 24 hour mean systolic Blood Pressure on Ambulatory Blood Pressure Monitoring (ABPM) at 16 weeks of treatment compared to baseline

Conditions

Interventions

DRUG

Nifidipine

Tablets 20 Mg daily for 4 weeks then combination therapy

DRUG

Telmisartan

Tablets 80 Mg daily for 4 weeks then combination therapy

DRUG

Nifedipine/Telmisartan

2 drugs (20 Mg Nifedipine/80 Mg Telmisartan) Combination therapy since the beginning

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-07-31
Completion
2009-08-31

Countries

  • Italy
  • Spain

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 NCT00750113 on ClinicalTrials.gov