Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT02260089
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : October 9, 2014
Sponsor:
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov 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:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action