Trial Outcomes & Findings for Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension (NCT NCT00454207)

NCT ID: NCT00454207

Last Updated: 2021-02-21

Results Overview

Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 44 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2021-02-21

Participant Flow

Eight centers in Japan

Twenty-one pulmonary arterial hypertension patients who have never received sildenafil therapy entered the study from Part I period and could continue to study part II period. Twenty-three patients who were continuously using sildenafil entered the study from Part II period.

Participant milestones

Measure	Sildenafil: Participant Who Entered the Study From Part I Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil: Participants Who Entered the Study From Part II Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
Overall Study STARTED	21	23
Overall Study COMPLETED	17	21
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Sildenafil: Participant Who Entered the Study From Part I Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil: Participants Who Entered the Study From Part II Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
Overall Study Adverse Event	3	1
Overall Study Lack of Efficacy	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

Baseline characteristics by cohort

Measure	Sildenafil: Participant Who Entered the Study From Part I n=21 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil: Participants Who Entered the Study From Part II n=23 Participants Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=93 Participants	20 Participants n=4 Participants	39 Participants n=27 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	21 Participants n=4 Participants	38 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Region of Enrollment Japan	21 participants n=93 Participants	23 participants n=4 Participants	44 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I	84.2 meters Standard Deviation 74.9	—	—	—

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I	-4.7 mmHg Standard Deviation 8.2	—	—	—

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I	-246.49 dyne·second/centimeter^5 Standard Deviation 301.17	—	—	—

PRIMARY outcome

Timeframe: Baseline, week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Cardiac output at Week 12 minus cardiac output at baseline

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I	0.556 liter/minute Standard Deviation 1.000	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline.

Change：6-minute walk distance at Week 8 minus 6-minute walk distance at baseline.

The 6-minute walk distance:Total distance walked during the 6- minute walk test.

Outcome measures

Measure	Sildenafil: Part I n=19 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I	87.5 meters Standard Deviation 75.3	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Systolic pulmonary arterial pressure at Week 12 minus Systolic pulmonary arterial pressure at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I	-3.4 mmHg Standard Deviation 13.4	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Diastolic pulmonary arterial pressure at Week 12 minus diastolic pulmonary arterial pressure at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I	-3.2 mmHg Standard Deviation 8.3	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Systolic systemic blood pressure at Week 12 minus systolic systemic blood pressure at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I	0.7 mmHg Standard Deviation 16.5	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Diastolic systemic blood pressure at Week 12 minus diastolic systemic blood pressure at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I	-3.1 mmHg Standard Deviation 9.0	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Mean systemic blood pressure:diastolic blood pressure+(systolic blood pressure-diastolic blood pressure)/3.

Change：Mean systemic blood pressure at Week 12 minus mean systemic blood pressure at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I	-0.9 mmHg Standard Deviation 12.9	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Pulmonary capillary wedge pressure at Week 12 minus pulmonary capillary wedge pressure at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I	0.68 mmHg Standard Deviation 3.14	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Right atrial pressure at Week 12 minus right atrial pressure at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I	-0.3 mmHg Standard Deviation 4.4	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Cardiac index at Week 12 minus cardiac index at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I	0.32 liter/minute/meter^2 Standard Deviation 0.62	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Heart rate at Week 12 minus heart rate at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I	-4.14 beats/minute Standard Deviation 7.45	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change:Pulmonary vascular resistance index at Week 12 minus pulmonary vascular resistance index at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I	-382.00 dyne*second/centimeter^5/meter^2 Standard Deviation 491.80	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Systemic vascular resistance at Week 12 minus systemic vascular resistance at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I	-265.77 dyne*second/centimeter^5 Standard Deviation 785.52	—	—	—

SECONDARY outcome

Timeframe: baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Systemic vascular resistance index at Week 12 minus systemic vascular resistance index at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I	-409.89 dyne*second/centimeter^5/meter^2 Standard Deviation 1271.30	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Mixed venous oxygen saturation at Week 12 minus mixed venous oxygen saturation at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I	2.91 percent saturation Standard Deviation 9.05	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Arterial oxygen saturation at Week 12 minus arterial oxygen saturation at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I	0.440 percent saturation Standard Deviation 5.437	—	—	—

SECONDARY outcome

Timeframe: baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Arterial oxygen partial pressure at Week 12 minus arterial oxygen partial pressure at baseline.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I	-2.02 mmHg Standard Deviation 11.17	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Partial pressure of mixed venous oxygen at Week 12 minus partial pressure of mixed venous oxygen at baseline.

Outcome measures

Measure	Sildenafil: Part I n=19 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I	0.57 mmHg Standard Deviation 4.35	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).

Outcome measures

Measure	Sildenafil: Part I Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II n=7 Participants Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III n=13 Participants Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I Functional class at Week 12:III	—	1 participants	7 participants	—
Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I Functional class at Week 12:I	—	0 participants	1 participants	—
Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I Functional class at Week 12:II	—	6 participants	5 participants	—
Changes in the World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension From Baseline at Weeks 12 in Participants Who Entered the Study From Part I Functional class at Week 12:IV	—	0 participants	0 participants	—

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward (Week 12).

Change：BORG dyspnoea score at Week 8 and Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I Week 8 (n=19, 0)	-0.84 scores on a scale Standard Deviation 1.89	—	—	—
Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I Week 12 (n=20, 6)	-0.95 scores on a scale Standard Deviation 1.94	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward (Week 12).

Change：Plasma brain natriuretic peptide level at Week 4, Week 8 and Week 12 minus plasma brain natriuretic peptide level at baseline

Outcome measures

Measure	Sildenafil: Part I n=20 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I Week 12 (n=20, 7)	-61.82 picograms/milliliter Standard Deviation 209.96	—	—	—
Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I Week 4 (n=20, 0)	-78.00 picograms/milliliter Standard Deviation 166.41	—	—	—
Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 4, Week 8 and Week 12 in Participants Who Entered the Study From Part I Week 8 (n=19, 0)	-88.25 picograms/milliliter Standard Deviation 178.39	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:Total distance walked during the 6- minute walk test.

Outcome measures

Measure	Sildenafil: Part I n=7 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II	-23.5 meters Standard Deviation 34.1	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

The cross-tabulation table on the WHO functional classes of pulmonary arterial hypertension at baseline and Week 12. The WHO functional classes of pulmonary arterial hypertension:Class I (pulmonary arterial hypertension patients with no limitation in physical activity) to Class IV (pulmonary arterial hypertension patients who can not perform a physical activity without any symptoms).

Outcome measures

Measure	Sildenafil: Part I n=1 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II n=6 Participants Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II Functional class at Week 12: I	1 participants	0 participants	—	—
Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II Functional class at Week 12: II	0 participants	5 participants	—	—
Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II Functional class at Week 12: III	0 participants	1 participants	—	—
Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II Functional class at Week 12: IV	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：BORG dyspnoea score at Week 12 minus BORG dyspnoea score at baseline. BORG dyspnoea score:Scale 0 (no breathlessness at all) to 10 (maximum). The score reflected the maximum degree of dyspnoea that the participants experienced at any time during the 6-minute walk distance.

Outcome measures

Measure	Sildenafil: Part I n=6 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II	0.33 scores on a scale Standard Deviation 1.21	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Full Analysis Set, including participants who took at least one dose of study medication and had efficacy measurements at both baseline and post-baseline. Last observation carried forward.

Change：Plasma brain natriuretic peptide level at Week 12 minus plasma brain natriuretic peptide level at baseline

Outcome measures

Measure	Sildenafil: Part I n=7 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II	15.91 picograms/milliliter Standard Deviation 55.94	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing

Maximum plasma concentrations was calculated from the observed value of plasma concentrations in each participant

Outcome measures

Measure	Sildenafil: Part I n=9 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320 Sildenafil	164.88 nanograms/milliliter Standard Deviation 74.78	—	—	—
Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320 Sildenafil's Metabolite, UK-103,320	87.27 nanograms/milliliter Standard Deviation 30.67	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing

Time to first occurrence of maximum plasma concentrations were calculated from the observed value of plasma concentrations in each participant.

Outcome measures

Measure	Sildenafil: Part I n=9 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320 Sildenafil	1.102 hours Standard Deviation 0.499	—	—	—
Time to First Occurrence of Maximum Plasma Concentrations (Tmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320 Sildenafil's Metabolite, UK-103,320	1.611 hours Standard Deviation 1.024	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing

The area under the curve from time 0 to time 8 hour was calculated from area under the curve in each perticipant on the date of blood sampling using the linear/log trapezoidal rule

Outcome measures

Measure	Sildenafil: Part I n=9 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320 Sildenafil	545.14 nanogram*hour/milliliter Standard Deviation 294.88	—	—	—
The Area Under the Curve (AUC) From Time 0 to Time 8 Hour of Sildenafil and Sildenafil's Metabolite, UK-103,320 Sildenafil's Metabolite, UK-103,320	365.85 nanogram*hour/milliliter Standard Deviation 186.55	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing

The average plasma concentration of sildenafil at steady state was calculated from the area under the curve from time 0 to 8 hour/dosing interval (8 hours).

Outcome measures

Measure	Sildenafil: Part I n=9 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
The Average Plasma Concentration (Css,av) of Sildenafil at Steady State	68.14 nanograms/milliliter Standard Deviation 36.86	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 hours after dosing

The average plasma trough concentration of sildenafil was calculated from the observed value before administration of the drug in each participants.

Outcome measures

Measure	Sildenafil: Part I n=9 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
The Average Plasma Trough Concentration (Ctrough) of Sildenafil	19.608 nanograms/milliliter Standard Deviation 12.438	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 1.3 years

Population: All subjects who received at least one dose of the study medication and had any evaluable laboratory test data after treatment.

The total number of participants with laboratory test abnormalities without regard to baseline abnormality.

Outcome measures

Measure	Sildenafil: Part I n=43 Participants Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil:Part I, Functional Class at Baseline: II Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline: III Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).	Sildenafil, Part I, Functional Class at Baseline:IV Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	35 participants	—	—	—

Adverse Events

Sildenafil: Part I and Part II

Serious events: 7 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sildenafil: Part I and Part II n=44 participants at risk Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period.
Cardiac disorders Cardiac failure	4.5% 2/44
Eye disorders Cataract	2.3% 1/44
Gastrointestinal disorders Nausea	2.3% 1/44
Infections and infestations Nasopharyngitis	2.3% 1/44
Infections and infestations Pneumonia	2.3% 1/44
Investigations Platelet count decreased	2.3% 1/44
Metabolism and nutrition disorders Anorexia	4.5% 2/44
Renal and urinary disorders Scleroderma renal crisis	2.3% 1/44
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	4.5% 2/44

Other adverse events

Measure	Sildenafil: Part I and Part II n=44 participants at risk Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period.
Gastrointestinal disorders Diarrhoea	9.1% 4/44
General disorders Oedema peripheral	6.8% 3/44
General disorders Pyrexia	11.4% 5/44
Infections and infestations Nasopharyngitis	38.6% 17/44
Injury, poisoning and procedural complications Fall	9.1% 4/44
Investigations Platelet count decreased	6.8% 3/44
Musculoskeletal and connective tissue disorders Back pain	6.8% 3/44
Nervous system disorders Dizziness	9.1% 4/44
Nervous system disorders Headache	25.0% 11/44
Psychiatric disorders Insomnia	6.8% 3/44
Respiratory, thoracic and mediastinal disorders Cough	6.8% 3/44
Respiratory, thoracic and mediastinal disorders Epistaxis	6.8% 3/44
Vascular disorders Flushing	22.7% 10/44

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
• Publication restrictions are in place

Restriction type: OTHER