Trial Outcomes & Findings for A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension (NCT NCT00430638)

NCT ID: NCT00430638

Last Updated: 2018-10-02

Results Overview

The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 278 participants
• Primary outcome timeframe: baseline to 12 weeks
• Results posted on: 2018-10-02

Participant Flow

Subjects were recruited at 29 US sites (private medical practices and small clinics) over 5 months from December 2006 to May 2007 from each physician's clientele base. About 450 potential subjects were to be screened so that about 250 eligible subjects, men and women at least 18 years of age with stage I or II hypertension, were randomized.

After 3-4 weeks of placebo treatment, eligible subjects were randomized. 140 were randomized to drug; 138 to placebo. 2 active drug participants were given the wrong dose at entry. Because only 138 participants received Olmesartan 20 mg, any demography data totals are equal to 276 instead of 278. The subgroup analyses are similarly affected.

Participant milestones

Measure	Placebo (Pbo) Group 138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.	Olmesartan Group 140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
Overall Study STARTED	138	140
Overall Study COMPLETED	60	92
Overall Study NOT COMPLETED	78	48

Reasons for withdrawal

Measure	Placebo (Pbo) Group 138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.	Olmesartan Group 140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
Overall Study Adverse Event	15	15
Overall Study Uncontrolled blood pressure	48	13
Overall Study Lost to Follow-up	1	7
Overall Study Protocol Violation	6	4
Overall Study Withdrawal by Subject	4	6
Overall Study Non-compliant	2	1
Overall Study Other	2	2

Baseline Characteristics

A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension

Baseline characteristics by cohort

Measure	Olmesartan Group n=138 Participants Participants were randomized to an olmesartan (Olm) based active treatment group. After 3,6,and 9 weeks of treatment participants were titrated to the next regiment if their blood pressure was greater than 120/80 mmHg. The active treatment group received olm 20 mg (weeks 1-3), olm 40 mg (weeks 4-6), olm 40 mg + 12.5 mg hydrchlorothiazide (HCTZ) (weeks 7-9), and olm 40 mg + 25 mg HCTZ (weeks 10-12).	Placebo Group n=138 Participants Participants were randomized to a placebo (Pbo) group. The Pbo participants remained in the pbo group for the entire 12 weeks of treatment.	Total n=276 Participants Total of all reporting groups
Age, Continuous	55.9 years FULL_RANGE 10.74 • n=5 Participants	55.8 years FULL_RANGE 9.47 • n=7 Participants	55.9 years FULL_RANGE 10.1 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	72 Participants n=7 Participants	147 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	66 Participants n=7 Participants	129 Participants n=5 Participants
Region of Enrollment United States	138 participants n=5 Participants	138 participants n=7 Participants	276 participants n=5 Participants
Diastolic BP	94.2 mm Hg FULL_RANGE 7.7 • n=5 Participants	93.7 mm Hg n=7 Participants	94.0 mm Hg n=5 Participants
Heart Rate	75.1 Beats/minute FULL_RANGE 10.84 • n=5 Participants	73.6 Beats/minute n=7 Participants	74.4 Beats/minute n=5 Participants
Systolic BP	156.9 mm Hg FULL_RANGE 9.19 • n=5 Participants	155.4 mm Hg n=7 Participants	156.2 mm Hg n=5 Participants

PRIMARY outcome

Timeframe: baseline to 12 weeks

Population: The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group. 139 is the correct number analyzed. For the placebo group the efficacy cohort = 137.

The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.

Outcome measures

Measure	Placebo n=137 Participants Patient received placebo tablets.	Olmesartan Group n=139 Participants Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.	-0.1 mm Hg Standard Error 1.40	-22.3 mm Hg Standard Error 1.39

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group, but two were erroneously started with the 40mg dose. 139 is the correct number analyzed.

Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach.

Outcome measures

Measure	Placebo n=137 Participants Patient received placebo tablets.	Olmesartan Group n=139 Participants Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device.	-0.8 mm Hg Standard Error 0.78	-12.1 mm Hg Standard Error 0.77

SECONDARY outcome

Timeframe: Baseline to week 12

Population: 131 male participants

The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed.

Outcome measures

Measure	Placebo n=131 Participants Patient received placebo tablets.	Olmesartan Group Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males. Systolic Blood Pressure	-22.6 mm Hg Standard Error 2.94	—
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males. Diastolic Blood Pressure	-13.5 mm Hg Standard Error 1.66	—

SECONDARY outcome

Timeframe: Baseline to week 12

Population: 145 female participants from both the olmesartan and placebo groups were analyzed.

The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed.

Outcome measures

Measure	Placebo n=145 Participants Patient received placebo tablets.	Olmesartan Group Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females. Systolic blood pressure	-21.6 mm Hg Standard Deviation 2.6	—
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females. Diastolic blood pressure	-12.0 mm Hg Standard Deviation 1.38	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 232 participants from both the olmesartan and placebo groups, less than 65 years of age, were analyzed.

Outcome measures

Measure	Placebo n=232 Participants Patient received placebo tablets.	Olmesartan Group Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old. Systolic blood pressure	-23.8 mm Hg Standard Deviation 2.04	—
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old. Diastolic blood pressure	-13.6 mm Hg Standard Deviation 1.17	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 44 participants of greater than 65 years of age, from both the olmesartan and placebo groups were analyzed.

Outcome measures

Measure	Placebo n=44 Participants Patient received placebo tablets.	Olmesartan Group Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old. Systolic blood pressure	-16.1 mm Hg Standard Deviation 6.18	—
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old. Diastolic blood pressure	-9.0 mm Hg Standard Deviation 2.42	—

SECONDARY outcome

Timeframe: Baseline to week 12

Population: 55 Black participants from both the olmesartan and placebo groups were analyzed.

Outcome measures

Measure	Placebo n=55 Participants Patient received placebo tablets.	Olmesartan Group Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants. Systolic blood pressure	-21.3 mm Hg Standard Deviation 4.97	—
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants. Diastolic blood pressure	-12.5 mm Hg Standard Deviation 2.72	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 221 non-Black participants from both the olmesartan and placebo groups were analyzed.

Outcome measures

Measure	Placebo n=221 Participants Patient received placebo tablets.	Olmesartan Group Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants. Systolic blood pressure	-22.3 mm Hg Standard Deviation 2.14	—
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants. Diastolic blood pressure	-12.8 mm Hg Standard Deviation 1.18	—

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: 130 Stage 1 hypertensive participants from both the olmesartan and placebo groups.

Outcome measures

Measure	Placebo n=130 Participants Patient received placebo tablets.	Olmesartan Group Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives Systolic blood pressure	-22.1 mm Hg Standard Deviation 2.43	—
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives Diastolic blood pressure	-12.2 mm Hg Standard Deviation 1.39	—

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: 146 Stage 2 hypertensive participants from both the olmesartan and placebo groups

Outcome measures

Measure	Placebo n=146 Participants Patient received placebo tablets.	Olmesartan Group Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives Systolic blood pressure	-22.5 mm Hg Standard Deviation 3.07	—
The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives Diastolic blood pressure	-13.2 mm Hg Standard Deviation 1.65	—

Adverse Events

Placebo (Pbo) Group

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Olmesartan Group

Serious events: 3 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo (Pbo) Group n=138 participants at risk 138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.	Olmesartan Group n=140 participants at risk 140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
Vascular disorders Hypertension	0.00% 0/138 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.	0.71% 1/140 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
Gastrointestinal disorders Small Intestine Obstruction	0.00% 0/138 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.	0.71% 1/140 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
Cardiac disorders Supraventricular tachycardia	0.00% 0/138 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.	0.71% 1/140 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.

Other adverse events

Measure	Placebo (Pbo) Group n=138 participants at risk 138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.	Olmesartan Group n=140 participants at risk 140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
Musculoskeletal and connective tissue disorders Back pain	2.9% 4/138 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.	5.7% 8/140 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 7/138 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.	2.1% 3/140 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
Nervous system disorders Dizziness	0.72% 1/138 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.	9.3% 13/140 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
Nervous system disorders Headache	12.3% 17/138 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.	7.9% 11/140 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
Vascular disorders Hypertension	0.72% 1/138 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.	2.1% 3/140 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
Immune system disorders Seasonal allergy	1.4% 2/138 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.	2.1% 3/140 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
Infections and infestations Upper respiratory tract infection	5.1% 7/138 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.	6.4% 9/140 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
Infections and infestations Urinary tract infection	0.00% 0/138 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.	2.9% 4/140 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
Infections and infestations Viral upper respiratory infection	5.1% 7/138 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.	0.71% 1/140 • 12-week randomized, treatment period plus 30 days after the last dose of study medication. All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.

Additional Information

Global Clinical Leader

Daiichi Sankyo

Phone: 1-908-992-6400

Results disclosure agreements

• Principal investigator is a sponsor employee If identified by Daiichi Sankyo Inc.(DSI), any of DSI's confidential information, as defined to the author, shall be deleted. Nothing in our site agreement shall be taken as giving DSI any right of editorial control over any publication prepared by the study site.
• Publication restrictions are in place

Restriction type: OTHER