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NCT00325936
A Multi-Center, Double-Blind, Randomized, Superiority Clinical Study to Compare the Effects of Cilnidipine on Metabolic Syndrome Improvement With Nifedipine GITS in Hypertensive Patients With Metabolic Syndrome (Phase IV) [SLIMS]
Phase 4 trial testing Cilnidipine in Hypertension in 186 participants. Completed in 1 June 2007.
1 June 2007
Quick facts
| Lead sponsor | Boryung Pharmaceutical Co., Ltd |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 186 |
| Start date | 1 July 2005 |
| Primary completion | 1 June 2007 |
| Estimated completion | 1 June 2007 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Cilnidipine (CILNIDIPINE) — full drug profile →
Conditions studied
- Hypertension — all drugs for Hypertension →
- Metabolic Syndrome X — all drugs for Metabolic Syndrome X →
Sponsor
Boryung Pharmaceutical Co., Ltd — full company profile →
Who can join
Adults 30 to 65, any sex, with Hypertension or Metabolic Syndrome X. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Homeostasis model assessment of insulin sensitivity (HOMA-IR)
Time frame: after 3 month and 12 month treatment -
Triglyceride/HDL cholesterol ratio
Time frame: after 3 month and 12 month treatment
Sponsor's own description
Abnormalities of glucose, insulin and lipoprotein metabolism are common in patients with hypertension, and these metabolic abnormalities are reported to be related to insulin resistance. Therefore, whenever treating such patients, antihypertensive agents that may have the added effect of improving insulin resistance should be selected. CinalongTM (Cilnidipine) is expected to improve metabolic syndrome as well as insulin resistance by its dual effects on L and N-type calcium (Ca) channels. In this study, the researchers investigate the effects of CinalongTM on insulin resistance and other metabolic related factors.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00325936
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypertension
Currently open trials in the same condition.
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- NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
- NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia · Phase 2 · recruiting
- NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting
Other Boryung Pharmaceutical Co., Ltd trials
Trials by the same sponsor.
- NCT07421414 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
- NCT07421401 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
- NCT07421388 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
- NCT07421375 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
- NCT07373613 — A Study of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential Hypertension · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00325936 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boryung Pharmaceutical Co., Ltd
- Last refreshed: 26 August 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00325936.
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