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OpenTrials
Completed

NCT Number: NCT02260089

Telmisartan in Mild to Moderate Hypertensive Patients

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

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose of telmisartan

Drug

High dose of telmisartan

Drug

Placebo

Drug

Primary outcomes

  1. Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP)

    Time frame: Baseline, up to 12 weeks after start of treatment

    Blood pressure values were obtained 24 hours after the last dose (through values) at the office

Secondary outcomes

  1. Assessment of treatment response for SBP/DBP (in %)

    Time frame: Baseline, up to 12 weeks after start of treatment

    Response categories:

    • SBP < 140 mm Hg or
    • DBP < 90 mm Hg or
    • BP reduction ≥ 10 mm Hg

  2. Changes from baseline in blood pressure values

    Time frame: Baseline, up to 12 weeks after start of treatment

    Analysis performed for the ambulatory blood pressure monitoring (ABPM) - subgroup

  3. Number of patients with adverse events

    Time frame: Up to 16 weeks

  4. Number of patients with clinically significant changes in laboratory values

    Time frame: Up to 16 weeks

  5. Number of patients with clinically significant changes in ECG

    Time frame: Up to 16 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Multicenter Open-label Study of the Efficacy and Safety of Telmisartan in Mild to Moderate Hypertensive Patients

Important dates

Study start
2000
Primary completion
2002
First posted
Oct 9, 2014
Registry last updated
Oct 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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