Trial intelligence / Profile preview

SLV306 Dose Finding in Hypertension

NCT00160212Phase 2

Key facts

Status
Completed
Start
Dec 2004
Countries
11
Sponsor
Solvay
Modality
Small Molecules
Conditions
hypertension (HTN)
01

Overview

Phase 2, randomised, double-blind trial of Daglutril in hypertension (HTN) (6 arms), sponsored by Solvay. Primary endpoints: Systolic Blood Pressure and Diastolic Blood Pressure. Started Dec 2004; status: completed.

02

Design

6 arms
Study design
RandomizedDouble-blind
  • SLV306 150 mg QD

    Daglutril 150 mg once daily

  • SLV306 300 mg QD

    Daglutril 300 mg once daily

  • SLV306 600 mg QD

    Daglutril 600 mg once daily

  • SLV306 150-300 mg BID

    Daglutril 150-300 mg twice daily

  • Amlodipine 5-10 mg QD

    Amlodipine 5-10 mg once daily

  • Placebo

    Placebo

03

Who it enrols

Patients with sitting office diastolic blood pressure between 90 and 109 mmHg, office systolic blood pressure between 140 and 179 mmHg, and mean day-time diastolic 24-h ABPM blood pressure >= 85 mmHg. Excludes secondary hypertension and decompensated congestive heart failure.

04

Endpoints

Primary

  • Systolic Blood Pressure

  • Diastolic Blood Pressure

Secondary

  • Adverse Events

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