To Evaluate Pharmacokinetics of LFF269 in Healthy Volunteers and Patients With Hypertension
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Part 1 - Healthy Volunteers, Part 2 - Patients With Hypertension
In brief
This study is designed to enable optimal dose selection of LFF269 for potential future studies by providing additional information about the compounds safety, tolerability, pharmacokinetic and pharmacodynamic profiles.
Key facts
- Study ID
- NCT02047656
- Run by
- Novartis Pharmaceuticals
- People needed
- 93
- Starts
- 2013-08-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2016-04-01
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Part 1
- Healthy men and women of non-childbearing potential, 18 to 80 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Part 2
- Hypertensive men and women of non-childbearing potential, 18 to 80 years of age inclusive.
- Patients with mild-to-moderate uncomplicated essential hypertension
You may not qualify if…
- Part 1
- History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes.
- A history of clinically significant ECG abnormalities.
- Known history or current clinically significant arrhythmias.
- History of hypertension, adrenal or endocrine disease.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
- Smokers (use of tobacco products in the previous 3 months).
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- A positive Hepatitis B surface antigen or Hepatitis C test result.
- Part 2
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential.
- Known history or evidence of a secondary form of hypertension
- Type 1 or type 2 diabetes mellitus.
- History of heart diseases
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- Other protocol defined inclusion/exclusion criteria may apply
Where it is running
- Novartis Investigative Site — Miami, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.