Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.44 enrolled

Overview

To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Hypertension

Interventions

sildenafil citrate (UK-92,480)DRUG

sildenafil citrate (UK-92,480)

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects aged 16 and over, and classified as having pulmonary arterial hypertension * Subjects who meet the following conditions on right heart catheterization at screening or baseline: mean pulmonary arterial pressure of ≥ 25mmHg and pulmonary capillary wedge pressure of ≤ 15mmHg at rest * Subjects whose baseline 6-Minute Walk test distance is \>100 m and \<450 m Exclusion Criteria: * Significant Hepatic and/or renal disorder * Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION) * Subjects who are currently receiving nitrates or nitric oxide donors in any form, ritonavir, ketoconazole and itraconazole

Locations (8)

Pfizer Investigational Site

Chiba, Chiba, Japan

Pfizer Investigational Site

Kanazawa, Ishikawa-ken, Japan

Pfizer Investigational Site

Tsu, Mie-ken, Japan

Pfizer Investigational Site

Okayama, Okayama-ken, Japan

Outcomes

Primary Outcomes

Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I

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.

Time frame: Baseline, Week 12

Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, week 12

Secondary Outcomes

Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I

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.

Time frame: Baseline, Week 8

Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Hamamatsu, Shizuoka, Japan

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Pfizer Investigational Site

Tokyo, Japan

Time frame: Baseline, Week 12

Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Mean Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

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.

Time frame: Baseline, Week 12

Change in the Pulmonary Capillary Wedge Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Right Atrial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Cardiac Index From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Heart Rate From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Pulmonary Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Systemic Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Systemic Vascular Resistance Index From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: baseline, Week 12

Change in the Mixed Venous Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Arterial Oxygen Saturation From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

Change in the Arterial Oxygen Partial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: baseline, Week 12

Change in the Partial Pressure of Mixed Venous Oxygen From Baseline at Week 12 in Participants Who Entered the Study From Part I

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

Time frame: Baseline, Week 12

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

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).

Time frame: Baseline, Week 12

Changes in the BORG Dyspnoea Score From Baseline at Week 8 and Week 12 in Participants Who Entered the Study From Part I

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.

Time frame: Baseline, Week 8, Week 12

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

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

Time frame: Baseline, Week 4, Week 8, Week 12

Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II

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.

Time frame: Baseline, Week 12

Change in the World Health Organization (WHO) Functional Class From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II

Time frame: Baseline, Week 12

Changes in the BORG Dyspnoea Score From Baseline at Week 12 in Participants Who Newly Entered the Study From Part II

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.

Time frame: Baseline, Week 12

Changes in the the Plasma Brain Natriuretic Peptide Level From Baseline at Week 12 in Participants Who Newly Enterd the Study From Part II

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

Time frame: Baseline, Week 12

Maximum Plasma Concentrations (Cmax) of Sildenafil and Sildenafil's Metabolite, UK-103,320

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