Telmisartan in Mild to Moderate Hypertensive Patients

NCT ID: NCT02260089

Last Updated: 2014-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Brief Summary

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To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low dose of telmisartan

4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan

Group Type EXPERIMENTAL

Low dose of telmisartan

Intervention Type DRUG

Placebo

Intervention Type DRUG

High dose of telmisartan

After 6 weeks of treatment with low dose of telmisartan, titration to high dose of telmisartan if blood pressure level is higher than 140/90 mm Hg

Group Type EXPERIMENTAL

High dose of telmisartan

Intervention Type DRUG

Interventions

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Low dose of telmisartan

Intervention Type DRUG

High dose of telmisartan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with blood pressure levels of 140/90 mm Hg or higher (confirmed on 2 consecutive visits), who were 18 years old and older, regardless of sex

Exclusion Criteria

* Suspected or known diagnosis of arterial hypertension with a secondary cause
* Women who were not using an effective method of contraception, or who were pregnant, or breast-feeding
* Systolic blood pressure \> 200 mm Hg or diastolic blood pressure \> 115 mm Hg
* Laboratory test values two fold above the upper normal limit
* Previous intolerance to angiotensin conversion enzyme inhibitors or angiotensin II blocker (AIIAR)
* New York Heart Association class III or IV heart failure
* History of stroke in the 6 months prior to entry into the study
* Uncontrolled type 2 diabetes mellitus, defined as fasting glucose levels \> 140 mg/dL on 3 consecutive assessments
* Patients who were included in another investigational drug study in the past 30 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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502.363

Identifier Type: -

Identifier Source: org_study_id

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