Study of Nifedipine GITS and Candesartan Combination Compared to Monotherapy in Patients With Essential Hypertension
Public ClinicalTrials.gov record NCT01303783. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Multifactorial, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of Nifedipine GITS and Candesartan in Combination Compared to Monotherapy in Adult Patients With Essential Hypertension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the blood pressure lowering responses of various dose combinations of nifedipine GITS and candesartan as compared to treatment with each component on their own (monotherapy) and placebo (a look-alike tablet without active ingredient). The drugs - nifedipine GITS and candesartan - which are being investigated are currently approved for use in patients with essential hypertension alone or together with other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS and candesartan used together in the treatment of essential hypertension has not been established yet. In this study patients will be treated with various doses of nifedipine GITS and/or candesartan or placebo. These different regimens will be administered once a day and will be assessed based on their blood pressure lowering effects (mean sitting diastolic blood pressure) in subjects with mild to moderate essential hypertension.
Study identification
- NCT ID
- NCT01303783
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 1,381 participants
Conditions and interventions
Conditions
Interventions
- Candesartan cilexetil (Atacand), 4 mg Drug
- Candesartan cilexetil (Atacand), 8 mg Drug
- Nifedipine GITS (Adalat, BAYA1040), 20 mg Drug
- Nifedipine GITS (Adalat, BAYA1040), 30 mg Drug
- Nifedipine GITS (Adalat, BAYA1040), 60 mg Drug
- Placebo Drug
- Candesartan cilexetil (Atacand), 16 mg Drug
- Candesartan cilexetil (Atacand), 32 mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2011 (Type not available)
- Primary completion
- May 2012 (Actual)
- Completion
- May 2012 (Actual)
- Last update posted
- Apr 18, 2017
2011 – 2012
United States locations
- U.S. sites
- 23
- U.S. states
- 12
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Mobile | Alabama | 36617 | — |
| Not listed | Los Angeles | California | 90057 | — |
| Not listed | Coral Gables | Florida | 33114-4192 | — |
| Not listed | Deerfield Beach | Florida | 33321 | — |
| Not listed | Deerfield Beach | Florida | 33441 | — |
| Not listed | Fort Lauderdale | Florida | 33309 | — |
| Not listed | Jacksonville | Florida | 32216 | — |
| Not listed | West Palm Beach | Florida | 33409 | — |
| Not listed | Atlanta | Georgia | 30338 | — |
| Not listed | Valparaiso | Indiana | 46383 | — |
| Not listed | Charlotte | North Carolina | 28209 | — |
| Not listed | Harrisburg | North Carolina | 28075 | — |
| Not listed | Raleigh | North Carolina | 27609 | — |
| Not listed | Salisbury | North Carolina | 28144 | — |
| Not listed | Cincinnati | Ohio | 45224 | — |
| Not listed | Philadelphia | Pennsylvania | 19142 | — |
| Not listed | Greenville | South Carolina | 29615 | — |
| Not listed | Mt. Pleasant | South Carolina | 29464 | — |
| Not listed | Dallas | Texas | 75230 | — |
| Not listed | San Antonio | Texas | 78205 | — |
| Not listed | Salt Lake City | Utah | 84109 | — |
| Not listed | Salt Lake City | Utah | 84121 | — |
| Not listed | Kenosha | Wisconsin | 53142 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 134 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01303783, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 18, 2017 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01303783 live on ClinicalTrials.gov.