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Efficacy and Safety of Chronic Administration of Telmisartan as Monotherapy or in Combination With Hydrochlorothiazide or Other Antihypertensive Medications in Patients With Mild to Moderate Hypertension

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ClinicalTrials.gov Identifier: NCT02177422
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The primary objective of this trial was to assess the efficacy and safety of telmisartan 80 mg during open-label, long-term treatment. An additional objective was to assess the efficacy and safety of concomitant administration of telmisartan 80 mg and HCTZ (Hydrochlorothiazide) and/or any other therapies commonly used in the treatment of hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan Drug: Hydrochlorothiazide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 489 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Follow-up Trial on Efficacy and Safety of Chronic Administration of Telmisartan 80 mg (Micardis®) Tablets as Monotherapy or in Combination With Hydrochlorothiazide or Other Antihypertensive Medications in Patients With Mild to Moderate Hypertension
Study Start Date : June 1998
Actual Primary Completion Date : November 1999

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telmisartan Drug: Telmisartan
telmisartan 80 mg once daily

Drug: Hydrochlorothiazide
12.5 mg or 25 mg Hydrochlorothiazide in addition to telmisartan in case that the goal response (mean sitting diastolic blood pressure < 90 mmHg) is not met after at least 4 weeks of treatment with telmisartan




Primary Outcome Measures :
  1. Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg [ Time Frame: Up to one year ]
  2. Need for addition of hydrochlorothiazide or subsequent change in antihypertensive therapy [ Time Frame: Up to one year ]
  3. Time to addition of hydrochlorothiazide or any subsequent change in antihypertensive therapy [ Time Frame: Up to one year ]
  4. Mean sitting diastolic blood pressure during each visit [ Time Frame: At months 3, 6, 9, 12 ]
  5. Mean sitting systolic blood pressure during each visit [ Time Frame: At months 3, 6, 9, 12 ]
  6. Number of patient with adverse events [ Time Frame: Up to one year ]
  7. Changes from baseline in heart rate [ Time Frame: Baseline and at months 3, 6, 9, 12 ]
  8. Number of patients with abnormal changes in 12-Lead ECG (electrocardiogram) [ Time Frame: Baseline and 12 months ]
  9. Number of patients with abnormal changes in laboratory parameters [ Time Frame: Baseline and 12 months ]
  10. Number of patients with abnormal findings in physical examination [ Time Frame: Baseline and at 12 month ]


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

Inclusion Criteria:

  • Patients who have met the inclusion criteria for the preceding clinical trial of telmisartan. All patients must give a separate written informed consent for participation in the open-label follow-up.

    • Mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer
    • Mean seated systolic blood pressure ≥ 140 mmHg, measured my manual cuff
    • A 24-hour mean diastolic blood pressure, measured by ABPM (ambulatory blood pressure measurement), of ≥ 85 mmHg
    • Age 18 or older
    • Patient's written informed consent in accordance with GCP (Good Clinical Practice) and local legislation

Exclusion Criteria:

  • Patients with a clinically significant change in ECG from baseline that was reported as an adverse event during the preceding clinical trial
  • Patients who have developed a medical condition during the preceding clinical trial that, in the investigator's opinion, may be worsened by treatment or may compromise the safety evaluation of telmisartan
  • Patients who discontinued the preceding telmisartan clinical trial due to an adverse event
  • Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02177422     History of Changes
Other Study ID Numbers: 502.260
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Hydrochlorothiazide
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists