A study of the effects that telmisartan has on the body's uptake of verapamil, and the preventative effects of verapamil on clusterheadache.

A study of the farmacokinetic effect of telmisartan on the serum concentration of verapamil and the prophylactic effect of verapamil on clusterheadache. - A farmacokinetic study of verapamil

Status

Active, not recruiting

Phases

Phase 1Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003513-41-DK

Enrollment

Registered

2011-09-22

Start date

2011-10-27

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Horton's Headache MedDRA version: 14.1 Level: LLT Classification code 10020397 Term: Horton's headache System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Telmisartan Product Name: Telmisartan Pharmaceutical Form: Coated tablet Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Trade Name: Verapamil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Phase 1: Healthy volunteers Phase 2: Horton's Headache patients Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 48 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Poor general health, intolerance to drugs being investigated, pregnancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase 2: To investigate the prophylactic effect of adding telmirsatan to verapamil in patients with cluster hehadache; a double blinded and placebo controlled design. ;Secondary Objective: Phase 1: To investigate an eventual change in the absorption of verapamil after adding telmisartan - a pharmacokinetic study. ;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: Phase 1: 2 weeks Phase 2: 3 weeks	—

Measure

Time frame

Main Objective: Phase 2: To investigate the prophylactic effect of adding telmirsatan to verapamil in patients with cluster hehadache; a double blinded and placebo controlled design. ;Secondary Objective: Phase 1: To investigate an eventual change in the absorption of verapamil after adding telmisartan - a pharmacokinetic study. ;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: Phase 1: 2 weeks Phase 2: 3 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026