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

NCT02261116 | Completed Phase 4

• 1 other identifier: 502.402
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Slope of PRA increase versus DR-1

  analysis of variance

  Predose and 2, 4, 8 h following trial medication

Secondary Outcomes (4)

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

  Predose and 2, 4, 8 h following trial medication

• Assessment of plasma aldosterone concentration after stimulation with Angiotensin II

  Predose and 2, 4, 8 h following trial medication

• Reactive response of the plasma renin activity (PRA)

  Predose and 2, 4, 8 h following trial medication

• Number of subjects with adverse events

  up to 42 days

Study Arms (3)

Telmisartan

EXPERIMENTAL

Drug: Telmisartan

Candesartan

ACTIVE COMPARATOR

Drug: Candesartan

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Telmisartan DRUG

Also known as: Micardis®

Telmisartan

Candesartan DRUG

Also known as: Blopress

Candesartan

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Telmisartan; candesartan; candesartan cilexetil

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 10, 2014
• Study Start: April 1, 2002
• Primary Completion: August 1, 2002
• Last Updated: October 10, 2014

Record last verified: 2014-10