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Telmisartan in Mild to Moderate Hypertensive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02260089
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : October 9, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Hypertension Drug: Low dose of telmisartan Drug: High dose of telmisartan Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Open-label Study of the Efficacy and Safety of Telmisartan in Mild to Moderate Hypertensive Patients
Study Start Date : March 2000
Actual Primary Completion Date : July 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: Low dose of telmisartan
4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan
Drug: Low dose of telmisartan
Drug: Placebo
Experimental: 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
Drug: High dose of telmisartan

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02260089     History of Changes
Other Study ID Numbers: 502.363
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: October 9, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action