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

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Candesartan; Drug: Placebo; Drug: Telmisartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02261116

502.402

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males, aged 18 to 45 years.
2. Absence of any relevant disease as determined by no clinically deviation from normal in medical history, clinical laboratory determination, ECGs and physical examinations
3. 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
4. Signed informed consent form
5. No intake of drugs inbetween a waiting time of ten times of half-life

Exclusion criteria

1. Contraindications to Ang II antagonists, known hypersensitivity, history of angioedema, serious allergy, asthma, allergic skin rash, significant allergic rhinitis or sensitivity to any drug
2. 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
3. Cerebrovascular diseases: history of stroke or transitory ischemic attacks (TIAs) or history of any cerebral bleeding
4. Renal diseases: serum creatinine >1.5 mg/dL
5. 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
6. Any history of alcohol or drug abuse
7. 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
8. Participation in any other investigational study, within the 30 days prior to enrolment
9. Blood donation within the previous 3 months
10. The investigator might disqualify a subject for a sound medical or psychiatric reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 3 patient groups, including a placebo group

Telmisartan

Experimental group

Treatment:

Drug: Telmisartan

Candesartan

Active Comparator group

Treatment:

Drug: Candesartan

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo