A multi-center, randomized, double-blind, placebo and active controlled, parallel group, dose finding study to evaluate the efficacy and safety of LCI699 compared to placebo after 8 weeks treatment in patients with essential hypertensio

Phase 2

Completed

• Conditions: high blood pressure; hypertension; increased arterial pressure; 10057166

• Registration Number: NL-OMON33817
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Male, non-fertile female;
- Age from 18 up to 75 years inclusive;
- Mild to moderate uncomplicated essential hypertension
- MSDBP (Mean Seated Diastolic Blood Pressure) *95 mmg and *110 mmHg at visit 3.

Exclusion Criteria

- Severe hypertension;
- History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind, stroke, transient ischemic attack (TIA), carotid artery stenosis, aortic aneurysm or peripheral arterial disease;
- Type 1 or 2 diabetes mellitus;
- Previous or current diagnosis of congestive heart failure (NYHA class II-IV).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the efficacy of any of 4 dose regimens (0.25 mg QD, 0.5mg QD, 1.0mg<br /><br>QD and 0.5MG BID) of LIC699 in patients with essential hypertension by testing<br /><br>the hypothesis that the reducation in mean sitting diastolic blood pressure<br /><br>(MSDBP) 23-26 hours post dose (11-14 hours post BID dosing) with LCI699 is<br /><br>superior to that with placebo after 8 weeks of treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>See protocol page 14, paragraph 3.2.</p><br>