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Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients

NCT ID: NCT01119937

Last Updated: 2013-01-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NVA237

50µg once daily

Group Type EXPERIMENTAL

NVA237

Intervention Type DRUG

50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®)

Tiotropium

18µg once daily

Group Type EXPERIMENTAL

Tiotropium

Intervention Type DRUG

18µg capsules for inhalation, delivered via HandiHaler®

Interventions

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NVA237

50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®)

Intervention Type DRUG

Tiotropium

18µg capsules for inhalation, delivered via HandiHaler®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Gold Guideline 2008.
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Patients with a post-bronchodilator FEV1 ≥30% and \< 80% of the predicted normal, and postbronchodilator FEV1/FVC \< 0.7 at Visit 2 (day -7)

Exclusion Criteria

* Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
* Patients requiring long term oxygen therapy
* Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions
* Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
* Patients in the active phase of a supervised pulmonary rehabilitation program
* Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Site Status

Novartis Investigative Site

Iizuka, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kitakyushu, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kitakyushu, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kurume, Fukuoka, Japan

Site Status

Novartis Investigative Site

Ōnojō, Fukuoka, Japan

Site Status

Novartis Investigative Site

Yanagawa, Fukuoka, Japan

Site Status

Novartis Investigative Site

Asahikawa, Hokkaido, Japan

Site Status

Novartis Investigative Site

Obihiro, Hokkaido, Japan

Site Status

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status

Novartis Investigative Site

Himeji, Hyōgo, Japan

Site Status

Novartis Investigative Site

Takarazuka, Hyōgo, Japan

Site Status

Novartis Investigative Site

Yabu, Hyōgo, Japan

Site Status

Novartis Investigative Site

Inashiki-gun, Ibaraki, Japan

Site Status

Novartis Investigative Site

Naka-gun, Ibaraki, Japan

Site Status

Novartis Investigative Site

Sashima-gun, Ibaraki, Japan

Site Status

Novartis Investigative Site

Morioka, Iwate, Japan

Site Status

Novartis Investigative Site

Kawasaki, Kanagawa, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Kochi, Kochi, Japan

Site Status

Novartis Investigative Site

Uji, Kyoto, Japan

Site Status

Novartis Investigative Site

Matsusaka, Mie-ken, Japan

Site Status

Novartis Investigative Site

Sendai, Miyagi, Japan

Site Status

Novartis Investigative Site

Nagaoka, Niigata, Japan

Site Status

Novartis Investigative Site

Nagaoka, Niigata, Japan

Site Status

Novartis Investigative Site

Kasaoka, Okayama-ken, Japan

Site Status

Novartis Investigative Site

Tsuyama, Okayama-ken, Japan

Site Status

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status

Novartis Investigative Site

Osaka, Osaka, Japan

Site Status

Novartis Investigative Site

Sakai, Osaka, Japan

Site Status

Novartis Investigative Site

Sayama, Osaka, Japan

Site Status

Novartis Investigative Site

Takatsuki, Osaka, Japan

Site Status

Novartis Investigative Site

Saitama, Saitama, Japan

Site Status

Novartis Investigative Site

Shimotsuka-gun, Tochigi, Japan

Site Status

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Nakano-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Ohta-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Yamagata, Yamagata, Japan

Site Status

Novartis Investigative Site

Ube, Yamaguchi, Japan

Site Status

Countries

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Japan

Other Identifiers

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CNVA237A1302

Identifier Type: -

Identifier Source: org_study_id

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