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Effects of single-pill combination of telmisartan/amlodipine and telmisartan/amlodipine/hydrochlorothiazide on 24-hour blood pressure (BP) reduction, 24-h BP variability and office BP control in patients with arterial hypertension – SATELLITE

Status
Completed
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504812-13-00
Acronym
KCT02/2023-SATELLITE
Enrollment
110
Registered
2024-01-16
Start date
2024-05-06
Completion date
2025-08-23
Last updated
2025-08-22

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

Conditions

Arterial hypertension

Brief summary

Mean absolute change of 24-hour SBP after 16 weeks of treatment (from baseline to Visit 7) with TIMP.

Detailed description

Mean change in average real variability of 24-hour SBP (ARVs) and mean change in average real variability of 24-hour DBP (ARVd) after 16 weeks of treatment (from baseline to Visit 7) with TIMP., Mean absolute change of 24-hour DBP after 16 weeks of treatment (from baseline to Visit 7) with TIMP., Mean absolute and relative changes of office SBP and DBP after 4, 8, 12 and 16 weeks of treatment (from baseline to Visit 3, Visit 4, Visit 5 and Visit 7, respectively) with TIMP., Mean absolute change of the calculated central SBP (cSBP) and calculated central DBP (cDBP) after 16 weeks of treatment (from baseline to Visit 7) with TIMP., Mean SI after 16 weeks of treatment (from baseline to Visit 7) with TIMP., Mean absolute changes of 24-hour SBP, separately in groups of dipping, extreme dipping and non-dipping patients after 16 weeks of treatment (from baseline to Visit 7) with TIMP., Mean absolute change of pulse wave velocity (PWV) after 16 weeks of treatment (from baseline to Visit 7) with TIMP.

Interventions

DRUGTelmisartan/Amlodipine/Hydrochlorothiazide
DRUGTeldipin
DRUG80 mg + 5 mg
DRUGtabletki
DRUGTamloset 40 mg/5 mg tabletta
DRUGTamloset 80 mg/10 mg tabletta
DRUGTelassmo 80 mg/10 mg tablete
DRUGTamloset 80 mg/5 mg tabletta
DRUG80 mg + 10 mg
DRUGTelassmo 40 mg/5 mg tablete
DRUG40 mg + 5 mg
DRUGTelassmo 80 mg/5 mg tablete

Sponsors

KRKA tovarna zdravil d.d. Novo mesto
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean absolute change of 24-hour SBP after 16 weeks of treatment (from baseline to Visit 7) with TIMP.

Secondary

MeasureTime frame
Mean change in average real variability of 24-hour SBP (ARVs) and mean change in average real variability of 24-hour DBP (ARVd) after 16 weeks of treatment (from baseline to Visit 7) with TIMP., Mean absolute change of 24-hour DBP after 16 weeks of treatment (from baseline to Visit 7) with TIMP., Mean absolute and relative changes of office SBP and DBP after 4, 8, 12 and 16 weeks of treatment (from baseline to Visit 3, Visit 4, Visit 5 and Visit 7, respectively) with TIMP., Mean absolute change of the calculated central SBP (cSBP) and calculated central DBP (cDBP) after 16 weeks of treatment (from baseline to Visit 7) with TIMP., Mean SI after 16 weeks of treatment (from baseline to Visit 7) with TIMP., Mean absolute changes of 24-hour SBP, separately in groups of dipping, extreme dipping and non-dipping patients after 16 weeks of treatment (from baseline to Visit 7) with TIMP., Mean absolute change of pulse wave velocity (PWV) after 16 weeks of treatment (from baseline to Visit 7) wit

Countries

Hungary, Poland, Slovenia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026