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KDF1901 Phase 3 in Essential Hypertension
NCT07116863Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2022
- Primary completion
- Jun 2024
- Countries
- 1
- Sponsor
- Kyungdong Pharmaceutical
- Modality
- Small Molecules
- Drugs
- chlorthalidone
- Conditions
- essential hypertension
01
Overview
Phase 3, randomised, double-blind trial of chlorthalidone in essential hypertension (2 arms), sponsored by Kyungdong Pharmaceutical. Primary endpoint: Change in Mean Sitting Systolic Blood Pressure at 8 weeks. Started Jun 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
KDF1901 group
Receives triple therapy (valsartan/amlodipine/chlorthalidone)
Dual Therapy group
Receives dual therapy (valsartan/amlodipine)
03
Who it enrols
Patients with essential hypertension uncontrolled on dual therapy (valsartan/amlodipine). Inclusion MSSBP ranges from 130-200 mmHg depending on comorbidities. Excludes severe CV disease, eGFR < 30.
04
Endpoints
Primary
Change in Mean Sitting Systolic Blood Pressure
Secondary
Change in Mean Sitting Systolic Blood Pressure
Change in Mean Sitting Diastolic Blood Pressure
Proportion of subjects achieving target blood pressure
Response rate
05
Results
Primary endpoints met
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