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OpenTrials
Completed

NCT Number: NCT02177422

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

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.

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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 3

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Telmisartan

Drug

telmisartan 80 mg once daily

Hydrochlorothiazide

Drug

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
1998
Primary completion
1999
First posted
Jun 27, 2014
Registry last updated
Jul 8, 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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