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Losartan-based Therapy in Diabetic and Uncontrolled Hypertensive Patients
NCT03978884Phase 4
Key facts
- Status
- Withdrawn
- Start
- Jun 2019
- Primary completion
- May 2020
- Countries
- 1
- Sponsor
- The University of the West Indies
- Modality
- Small Molecules
- Drugs
- losartan
- Conditions
- hypertension (HTN)
01
Overview
Phase 4, open-label trial of losartan in hypertension (HTN) (4 arms), sponsored by The University of the West Indies. Primary endpoint: Proportion of Subjects achieving Target Blood Pressure at 12 weeks. Planned start Jun 2019; status: withdrawn.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Mild Hypertensive
Systolic BP 140-159 mmHg, Diastolic 90-99 mmHg
Mild Hypertensive with Diabetes
Systolic BP 140-159 mmHg, Diastolic 90-99 mmHg with Diabetes
Severe Hypertension
Systolic BP >= 160 mmHg or Diastolic >= 100 mmHg
Severe Hypertension with Diabetes
Systolic BP >= 160 mmHg or Diastolic >= 100 mmHg with Diabetes
03
Who it enrols
Adult patients with newly diagnosed or uncontrolled hypertension (BP > 140/90 mmHg). Patients with diabetes are included. Patients with chronic renal failure or serum creatinine > 150 µmol/L are excluded.
04
Endpoints
Primary
Proportion of Subjects achieving Target Blood Pressure
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