Completed

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

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What is being tested

LCI699

Drug
Who is being recruted

Adrenal Gland Diseases+8

+ Adrenocortical Hyperfunction

+ Cardiovascular Diseases

From 18 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2008
See protocol details

Summary

Principal SponsorNovartis
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2008

Actual date on which the first participant was enrolled.

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

Official TitleA 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
NCT00732771
Principal SponsorNovartis
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Adrenal Gland DiseasesAdrenocortical HyperfunctionCardiovascular DiseasesEndocrine System DiseasesHyperaldosteronismHypertensionHypokalemiaMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesWater-Electrolyte Imbalance

Criteria

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/exclusion criteria may apply

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Novartis Investigator Site

France, FranceOpen Novartis Investigator Site in Google Maps
CompletedOne Study Center