Trial · NCT00300365

Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL

NCT00300365, Phase 2, Completed, University of Pennsylvania; results first posted 2017-07-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL. Trials, record NCT00300365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00300365

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL
NCT number: NCT00300365
Status: Completed
Phases: Phase 2
Enrollment: 38 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Metabolic Syndrome
Interventions: Pioglitazone, Placebo, Niacin ER, Aspirin
First posted: 2006-03-08
Last updated: 2017-07-28
Results first posted: 2017-07-28

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks	Baseline, after 12 weeks of pioglitazone vs placebo	Mean increase in HDL-C from baseline (week -4) to 12 weeks post randomization in non-diabetic subjects with low HDL-C and metabolic syndrome. After baseline, all subjects titrated niacin extended release (ER) to 2 grams (g) daily over 4 weeks. Subjects were also given 325 mg aspirin to take 30 minutes before the niacin ER. After 4 weeks, half of the subjects added blinded pioglitazone 30mg/day (milligrams/day) for 6 weeks followed by 45 mg/day for 6 weeks; the other half added placebo. HDL-C was was assessed at baseline and 12 weeks post randomization

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks	Baseline, after 12 weeks of pioglitazone vs placebo	All subjects for whom HDL-C measurements were recorded at baseline (week -4) and 12 weeks post randomization to placebo, niacin ER, and aspirin or pioglitazone, niacin ER, and aspirin	mg/dL	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks	Pioglitazone Placebo + Open-Label Niacin + Aspirin	Baseline HDL-C	37.4	95% Confidence Interval 36.0 to 38.8	mg/dL
Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks	Active Pioglitazone + Open-Label Niacin + Asprin	Baseline HDL-C	36.2	95% Confidence Interval 34.8 to 37.6	mg/dL
Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks	Pioglitazone Placebo + Open-Label Niacin + Aspirin	HDL-C 12 weeks Post Randomization	40.6	95% Confidence Interval 38.8 to 42.6	mg/dL
Mean Increase in High Density Lipoprotein Cholesterol (HDL-C) at Baseline and 12 Weeks	Active Pioglitazone + Open-Label Niacin + Asprin	HDL-C 12 weeks Post Randomization	44.2	95% Confidence Interval 42.2 to 46.2	mg/dL

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pioglitazone Placebo + Open-Label Niacin + Aspirin	38
Overall Study	STARTED	Active Pioglitazone + Open-Label Niacin + Aspirin	40
Overall Study	COMPLETED	Pioglitazone Placebo + Open-Label Niacin + Aspirin	34
Overall Study	COMPLETED	Active Pioglitazone + Open-Label Niacin + Aspirin	38
Overall Study	NOT COMPLETED	Pioglitazone Placebo + Open-Label Niacin + Aspirin	4
Overall Study	NOT COMPLETED	Active Pioglitazone + Open-Label Niacin + Aspirin	2

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Leg Edema	Blood and lymphatic system disorders	Pioglitazone Placebo + Open-Label Niacin + Aspirin	6	38	6
other	Leg Edema	Blood and lymphatic system disorders	Active Pioglitazone + Open-Label Niacin + Asprin	6	40	8
other	Flushing	Skin and subcutaneous tissue disorders	Pioglitazone Placebo + Open-Label Niacin + Aspirin	4	38	4
other	Flushing	Skin and subcutaneous tissue disorders	Active Pioglitazone + Open-Label Niacin + Asprin	7	40	7
other	Itching	Skin and subcutaneous tissue disorders	Pioglitazone Placebo + Open-Label Niacin + Aspirin	6	38	6
other	Itching	Skin and subcutaneous tissue disorders	Active Pioglitazone + Open-Label Niacin + Asprin	2	40	2
serious	Hospitalization for Depression	Psychiatric disorders	Pioglitazone Placebo + Open-Label Niacin + Aspirin	0	38	0
serious	Hospitalization for Depression	Psychiatric disorders	Active Pioglitazone + Open-Label Niacin + Asprin	1	40	1
serious	Hospitalization for Shortness of Breath	Respiratory, thoracic and mediastinal disorders	Pioglitazone Placebo + Open-Label Niacin + Aspirin	1	38	1
serious	Hospitalization for Shortness of Breath	Respiratory, thoracic and mediastinal disorders	Active Pioglitazone + Open-Label Niacin + Asprin	0	40	0

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pioglitazone Placebo + Open-Label Niacin + Aspirin
Total, all-cause mortality	Active Pioglitazone + Open-Label Niacin + Asprin
Total, other adverse events	Pioglitazone Placebo + Open-Label Niacin + Aspirin	16	38
Total, other adverse events	Active Pioglitazone + Open-Label Niacin + Asprin	15	40
Total, serious adverse events	Pioglitazone Placebo + Open-Label Niacin + Aspirin	3	38
Total, serious adverse events	Active Pioglitazone + Open-Label Niacin + Asprin	2	40

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Pioglitazone Placebo + Open-Label Niacin + Aspirin vs Active Pioglitazone + Open-Label Niacin + Asprin: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00300365

GET https://conductscience.org/api/trials/v1/NCT00300365/registered

API reference For AI assistants