The Efficacy and Safety of Vardenafil in the Treatment of Pulmonary Arterial Hypertension

NCT00718952 | Completed Phase 3 DMC

• 1 other identifier: EVALUATION-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of vardenafil in the treatment of pulmonary arterial hypertension.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• The change in exercise capacity, as measured by the total distance walked in six minutes

  at week 12 and week 24

Secondary Outcomes (6)

• The reduction of mean pulmonary-artery pressure(mPAP)and pulmonary vascular resistance(PVR)

  at week 12 and week 24

• The increase of cardiac output(CO)

  at week 12 and week 24

• The increase of Peripheral Saturation of oxygen(SPO2)

  at week 12 and week 24

• The change in the Borg dyspnea index(a measure of perceived breathlessness on a scale of 0 to 10, with higher values indicating more severe dyspnea)

  at week 12 and week 24

• The change in World Health Organization (WHO) functional classification of pulmonary arterial hypertension (an adaptation of the New York Heart Association classification)

  at week 12 and week 24

Study Arms (2)

A

EXPERIMENTAL

Patients in group A will receive vardenafil in double-blinded treatment period.

Drug: Vardenafil

B

PLACEBO COMPARATOR

Patients in group A will receive placebo in double-blinded treatment period.

Drug: Placebo; Drug: Vardenafil

Interventions

Vardenafil DRUG

vardenafil tablet 5mg once-daily orally in the first 4 weeks while 5mg twice-daily orally in the following 8 weeks.

Also known as: Levitra

A

Placebo DRUG

Placebo tablet 5mg once-daily orally in the first 4 weeks while 5mg twice-daily orally in the following 8 weeks.

B

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 12-65.
• Confirmed idiopathic pulmonary hypertension, connective tissue disease associated pulmonary hypertension, congenital heart disease(with Eisenmenger syndrome) associated pulmonary hypertension.
• Baseline 6-minutes walking distance 150m-550m.
• WHO pulmonary hypertension function II-III with non-responder to calcium channel blockers.
• Documented written informed consent.

You may not qualify if:

• The other types of pulmonary hypertension.
• Subjects who refuse to subscribe written informed consents or can't cooperate with the trial well.
• Subjects with serious acute or chronic disease involved liver, kidney, and brain or have to use potent CYP3A4-inhibitor or nitrate to treat the underlying diseases.
• Subjects who are currently treated with sildenafil for PAH or taking sildenafil or tadalafil.
• Other contraindications in package insert.

Sponsors & Collaborators

• Tongji University: lead

Study Sites (10)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100043, China

Location

Peking Union Hospital, Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

Location

Beijing Shijitan Hospital, Peking University

Beijing, Beijing Municipality, China

Location

The First Clinical College of Harbin Medical University

Harbin, Heilongjiang, China

Location

Xiangya Hospital, Central-South University

Changsha, Hunan, 410008, China

Location

The General Hospital of Shenyang Military Command

Shenyang, Liaoning, China

Location

Renji Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

Location

The First Affiliated Hospital of Medical College of Xian Jiaotong University

Xi’an, Shanxi, 710061, China

Location

Shanghai Pulmonary Hospital ,Tongji University

Shanghai, 200433, China

Location

Related Publications (9)

• Barst RJ, Rubin LJ, Long WA, McGoon MD, Rich S, Badesch DB, Groves BM, Tapson VF, Bourge RC, Brundage BH, Koerner SK, Langleben D, Keller CA, Murali S, Uretsky BF, Clayton LM, Jobsis MM, Blackburn SD, Shortino D, Crow JW; Primary Pulmonary Hypertension Study Group. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. N Engl J Med. 1996 Feb 1;334(5):296-301. doi: 10.1056/NEJM199602013340504.

  PMID: 8532025 BACKGROUND

• Olschewski H, Simonneau G, Galie N, Higenbottam T, Naeije R, Rubin LJ, Nikkho S, Speich R, Hoeper MM, Behr J, Winkler J, Sitbon O, Popov W, Ghofrani HA, Manes A, Kiely DG, Ewert R, Meyer A, Corris PA, Delcroix M, Gomez-Sanchez M, Siedentop H, Seeger W; Aerosolized Iloprost Randomized Study Group. Inhaled iloprost for severe pulmonary hypertension. N Engl J Med. 2002 Aug 1;347(5):322-9. doi: 10.1056/NEJMoa020204.

  PMID: 12151469 BACKGROUND

• Simonneau G, Barst RJ, Galie N, Naeije R, Rich S, Bourge RC, Keogh A, Oudiz R, Frost A, Blackburn SD, Crow JW, Rubin LJ; Treprostinil Study Group. Continuous subcutaneous infusion of treprostinil, a prostacyclin analogue, in patients with pulmonary arterial hypertension: a double-blind, randomized, placebo-controlled trial. Am J Respir Crit Care Med. 2002 Mar 15;165(6):800-4. doi: 10.1164/ajrccm.165.6.2106079.

  PMID: 11897647 BACKGROUND

• Rubin LJ, Badesch DB, Barst RJ, Galie N, Black CM, Keogh A, Pulido T, Frost A, Roux S, Leconte I, Landzberg M, Simonneau G. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med. 2002 Mar 21;346(12):896-903. doi: 10.1056/NEJMoa012212.

  PMID: 11907289 BACKGROUND

• Galie N, Humbert M, Vachiery JL, Vizza CD, Kneussl M, Manes A, Sitbon O, Torbicki A, Delcroix M, Naeije R, Hoeper M, Chaouat A, Morand S, Besse B, Simonneau G; Arterial Pulmonary Hypertension and Beraprost European (ALPHABET) Study Group. Effects of beraprost sodium, an oral prostacyclin analogue, in patients with pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol. 2002 May 1;39(9):1496-502. doi: 10.1016/s0735-1097(02)01786-2.

  PMID: 11985913 BACKGROUND

• Ghofrani HA, Wiedemann R, Rose F, Olschewski H, Schermuly RT, Weissmann N, Seeger W, Grimminger F. Combination therapy with oral sildenafil and inhaled iloprost for severe pulmonary hypertension. Ann Intern Med. 2002 Apr 2;136(7):515-22. doi: 10.7326/0003-4819-136-7-200204020-00008.

  PMID: 11926786 BACKGROUND

• Michelakis E, Tymchak W, Lien D, Webster L, Hashimoto K, Archer S. Oral sildenafil is an effective and specific pulmonary vasodilator in patients with pulmonary arterial hypertension: comparison with inhaled nitric oxide. Circulation. 2002 May 21;105(20):2398-403. doi: 10.1161/01.cir.0000016641.12984.dc.

  PMID: 12021227 BACKGROUND

• Galie N, Ghofrani HA, Torbicki A, Barst RJ, Rubin LJ, Badesch D, Fleming T, Parpia T, Burgess G, Branzi A, Grimminger F, Kurzyna M, Simonneau G; Sildenafil Use in Pulmonary Arterial Hypertension (SUPER) Study Group. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 2005 Nov 17;353(20):2148-57. doi: 10.1056/NEJMoa050010.

  PMID: 16291984 BACKGROUND

• Ghofrani HA, Voswinckel R, Reichenberger F, Olschewski H, Haredza P, Karadas B, Schermuly RT, Weissmann N, Seeger W, Grimminger F. Differences in hemodynamic and oxygenation responses to three different phosphodiesterase-5 inhibitors in patients with pulmonary arterial hypertension: a randomized prospective study. J Am Coll Cardiol. 2004 Oct 6;44(7):1488-96. doi: 10.1016/j.jacc.2004.06.060.

  PMID: 15464333 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Zhi-Cheng Jing, MD

  Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 21, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: February 12, 2010

Record last verified: 2010-02

Locations

CN (10)