NCT00732771

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Last Updated

August 26, 2009

Status Verified

August 1, 2009

Enrollment Period

11 months

First QC Date

August 5, 2008

Last Update Submit

August 25, 2009

Conditions

Primary Hyperaldosteronism

Keywords

primary hyperaldosteronismhypokalemiahypertensionaldosterone synthase inhibitor

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure over a 7-week forced titration treatment period

    7 weeks

Secondary Outcomes (1)

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

    7 weeks

Study Arms (1)

LCI696 1mg bid

EXPERIMENTAL
Drug: LCI699

Interventions

LCI699DRUG
LCI696 1mg bid

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigator Site

France, France

Location

Related Publications (2)

  • Schumacher CD, Steele RE, Brunner HR. Aldosterone synthase inhibition for the treatment of hypertension and the derived mechanistic requirements for a new therapeutic strategy. J Hypertens. 2013 Oct;31(10):2085-93. doi: 10.1097/HJH.0b013e328363570c.

    PMID: 24107737DERIVED

  • Amar L, Azizi M, Menard J, Peyrard S, Watson C, Plouin PF. Aldosterone synthase inhibition with LCI699: a proof-of-concept study in patients with primary aldosteronism. Hypertension. 2010 Nov;56(5):831-8. doi: 10.1161/HYPERTENSIONAHA.110.157271. Epub 2010 Sep 13.

    PMID: 20837883DERIVED

MeSH Terms

Conditions

HyperaldosteronismHypokalemiaHypertension

Interventions

Osilodrostat

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Novartis

    Novartis investigator site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 12, 2008

Study Start

June 1, 2008

Primary Completion

May 1, 2009

Last Updated

August 26, 2009

Record last verified: 2009-08

Locations

FR(1)