Atorvastatin in Pulmonary Hypertension

NCT00615823 | Completed Phase 2 DMC

• 3 other identifiers: 2006-11522006BAI01A072005-1018
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical effect and tolerability of atorvastatin versus placebo in patients with Pulmonary Hypertension: double-blinded, randomised, prospective phase II study for 6 months with adjusted doses of Atorvastatin

Conditions

Hypertension, Pulmonary

Keywords

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• The placebo-corrected change from baseline to week 24 in 6-minute walk distance

  Measured at 6 months

Secondary Outcomes (4)

• Time from randomization to clinical worsening

  Measured at 6 months

• Change from baseline to week 24 in World Health Organization functional class

  measured at 6 monthes

• Change from baseline to week 24 in Borg dyspnea score

  measured at 6 monthes

• Change from baseline to week 24 in hemodynamic parameters derived from right heart catheterization.

  measured at 6 monthes

Study Arms (2)

1

ACTIVE COMPARATOR

Atorvastatin group: receive atorvastatin 10 mg daily in addition to supportive care

Drug: Atorvastatin

2

PLACEBO COMPARATOR

Placebo group: receive matching placebo in addition to supportive care.

Drug: Placebo

Interventions

Atorvastatin DRUG

Patients were assigned to receive 10 mg of atorvastatin for 6 months (supplied by JiaLin Pharmaceutical Co., Beijing, China). The dose was adjusted to 5mg daily if serum transaminase levels increased by less than three times the upper limit of normal or creatine kinase levels increased to less than five times the upper limit of normal. If serum transaminase and creatine kinase levels remained normal and low-density lipoprotein level greater than 3.4mmol/L after 4 weeks of therapy, the dose of drug was increased to 20mg once daily.

Also known as: atorvastatin: a'le(bland names)

1

Placebo DRUG

Patients were assigned to receive 10 mg of placebo for 6 months (supplied by JiaLin Pharmaceutical Co., Beijing, China). The dose was adjusted to 5mg daily if serum transaminase levels increased by less than three times the upper limit of normal or creatine kinase levels increased to less than five times the upper limit of normal. If serum transaminase and creatine kinase levels remained normal and low-density lipoprotein level greater than 3.4mmol/L after 4 weeks of therapy, the dose of drug was increased to 20mg once daily.

Also known as: matching placebo: a'le(brand name)

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and willing to sign the informed consent form
• \<=65 and \>=18years old
• Diagnosis of pulmonary arterial hypertension (Mean pulmonary artery pressure greater than 25 mm Hg at rest with a pulmonary capillary wedge pressure less than 15 mm Hg )that is a) idiopathic, b) familial, or c) associated with connective-tissue disease, d)congenital systemic-to-pulmonary shunt occurring after surgical/interventional repair that had been performed at least five years previously or in the absence of indications for surgery/intervention treatment e) chronic thromboembolism PAH in the absence of indications for surgery
• Patients in WHO functional class II to III
• Vasodilator Testing nonresponders
• Baseline six-minute walking distance between 100 and 460 m

You may not qualify if:

• PAH related to other etiologies (Groups 2, 3 and 5 pulmonary hypertension)
• A forced expiratory volume in one second/ forced vital capacity bellow 50% or a total lung capacity of less than 60 percent predicted value
• A 6-minute walk distance of less than 100 or more than 460 m
• A positive acute vasodilator response
• Current treatment with calcium-channel blockers or specific therapy (endothelin receptor antagonist, phosphodiesterase-5 inhibitor, or prostacyclin)
• Inability to perform 6-minute walk test
• Serum transaminase level three times above the upper limit of normal
• Creatine kinase level five times above the upper limit of normal
• Previously diagnosed heart disease such as serious cardiac arrhythmias, unstable angina pectoris, myocardial infarction
• History of transient ischemia attack or stroke within three months
• Bleeding disorder
• Positive pregnancy test or breastfeeding practice
• History or suspicion of inability to cooperate

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• National Grant from The Ministry of Science and Technology: collaborator
• Capital Development Scientific Fund: collaborator

Study Sites (1)

Cardiovascular Institute and Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (1)

• Zeng WJ, Xiong CM, Zhao L, Shan GL, Liu ZH, Xue F, Gu Q, Ni XH, Zhao ZH, Cheng XS, Wilkins MR, He JG; Atorvastatin in Pulmonary Arterial Hypertension (APATH) Study Group. Atorvastatin in pulmonary arterial hypertension (APATH) study. Eur Respir J. 2012 Jul;40(1):67-74. doi: 10.1183/09031936.00149011. Epub 2012 Feb 23.

  PMID: 22362846 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Jianguo He, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 14, 2008
• Study Start: February 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 23, 2012

Record last verified: 2012-02

Locations

CN (1)