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

A Pilot, Single-blind, Forced-titration Study to Assess the Hemodynamic and Hormonal Effects, Safety and Tolerability of the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00732771

Enrollment

Registered

2008-08-12

Start date

2008-06-30

Completion date

Unknown

Last updated

2009-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hyperaldosteronism

Keywords

primary hyperaldosteronism, hypokalemia, hypertension, aldosterone synthase inhibitor

Brief summary

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

Interventions

DRUGLCI699

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Systolic blood pressure over a 7-week forced titration treatment period	7 weeks

Secondary

Measure	Time frame
Plasma and urine hormone levels and electrolytes, diastolic blood pressure and drug pharmacokinetics over a 7-week forced titration treatment period	7 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026