Proof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Brief Summary

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The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can lower BP in patients with Primary hyperaldosteronism.

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Detailed Description

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Conditions

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Primary Hyperaldosteronism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LCI696 1mg bid

Group Type EXPERIMENTAL

LCI699

Intervention Type DRUG

Interventions

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LCI699

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of primary hyperaldosteronism (PH) within the last 3 years, either with or without an aldosterone producing adenoma (APA).
* Hypertension at screening

Exclusion Criteria

* Persistent hypokalemia
* Renal impairment
* Significant hepatic disease
* Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No