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OpenTrials
Completed

NCT Number: NCT02261116

Study to Assess Potential Different Properties of Telmisartan Compared to Candesartan in Healthy Volunteers

Study to assess potential different properties of telmisartan, which due to its Vd, should result in stronger "beneficial" effects of AT1 blockade in tissues (e.g. aldosterone suppression and renin increase) plus stronger AT2 stimulation compared to candesartan

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males, aged 18 to 45 years.
  • Absence of any relevant disease as determined by no clinically deviation from normal in medical history, clinical laboratory determination, ECGs and physical examinations
  • Systolic blood pressure (SBP) between 100 and 140 mmHg systolic and below 85 mmHg diastolic (both left and right arm) and a heart rate of ≥50 bpm
  • Signed informed consent form
  • No intake of drugs inbetween a waiting time of ten times of half-life

Exclusion criteria

  • Contraindications to Ang II antagonists, known hypersensitivity, history of angioedema, serious allergy, asthma, allergic skin rash, significant allergic rhinitis or sensitivity to any drug
  • History of cardiovascular diseases: any clinically significant cardio-vascular disease, a supine diastolic blood pressure >86 mmHg and systolic >141 mmHg measured by a standard sphygmomanometer or a heart rate ≤49 bpm
  • Cerebrovascular diseases: history of stroke or transitory ischemic attacks (TIAs) or history of any cerebral bleeding
  • Renal diseases: serum creatinine >1.5 mg/dL
  • Gastrointestinal/Hepatic diseases: Aspartate aminotransferase (ASAT) >40 U/l or Alanine aminotransferase (ALAT) >40 U/L, serum bilirubin >2x upper limit of normal, history of malabsorption or inability to tolerate oral medication, history of gastric or duodenal ulcers, history of significant gastrointestinal bleeding, history of hepatitis within the past years
  • Any history of alcohol or drug abuse
  • Use of any of the following drugs within 4 weeks of study enrolment (e.g. agents known to induce drug metabolizing enzymes): anabolic steroids and corticoids, antiarrhythmics (amiodarone, mexiletine, quinidine, propafenone), antibiotics (chloramphenicol, tetracyclines, sulfonamides, macrolides, cephalosporins, rifampicin, nalidixic acid), antiepileptics (phenytoin, carbamazepine), antifungals (e.g. griseofulvin), barbiturates, cimetidine, ethacrynic acid, fibrates, furosemide, haloperidol, lipid lowering agents (cholestyramine, hydroxymethylglutaryl, coenzyme A (HMG CoA) reductase inhibitors, dextrothyroxin), thyroid replacement therapy hormones or thyrostatics (thioureylene-type). The use of nonsteroidal antiinflammatory drugs (NSAIDs) should be discontinued 2 weeks prior to study enrolment, the one exception of aspirin should be one (1) week prior to study enrolment
  • Participation in any other investigational study, within the 30 days prior to enrolment
  • Blood donation within the previous 3 months
  • The investigator might disqualify a subject for a sound medical or psychiatric reason

Treatment and study plan

Telmisartan

Drug

Other names: Micardis®

Candesartan

Drug

Other names: Blopress

Placebo

Drug

Primary outcomes

  1. Slope of PRA increase versus DR-1

    Time frame: Predose and 2, 4, 8 h following trial medication

    analysis of variance

Secondary outcomes

  1. Assessment of angiotensin-1 (AT1) pressor antagonism in vivo (DR-1)

    Time frame: Predose and 2, 4, 8 h following trial medication

    rightward shift (DR-1) of diastolic blood pressure response to Angiotensin II dose escalating challenges

  2. Assessment of plasma aldosterone concentration after stimulation with Angiotensin II

    Time frame: Predose and 2, 4, 8 h following trial medication

  3. Reactive response of the plasma renin activity (PRA)

    Time frame: Predose and 2, 4, 8 h following trial medication

  4. Number of subjects with adverse events

    Time frame: up to 42 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Does Telmisartan Compared to Candesartan Due to a Distinctly Larger Volume of Distribution Exert Stronger Effects in Relevant Peripheral Tissues, e.g. Renal and Adrenal Tissues

Important dates

Study start
2002
Primary completion
2002
First posted
Oct 10, 2014
Registry last updated
Oct 10, 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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